Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Better Bioprocessing Efficiency Through Centralized OrchestrationMerck Life Sciences
Use this link to participate in the interactive on-demand webinar: http://bit.ly/Bio4COrchestrator
Detailed description:
In this talk, we discuss how orchestration software improves bioprocessing efficiency through the centralized configuration and management of connected unit operations for process and workflow automation across the plant floor.
A browser-based software solution, Bio4C™ Orchestrator software connects to individual unit operations from a centralized orchestration layer for remote access to systems, recipes, reports, user accounts and alarms from a holistic process dashboard.
Better Bioprocessing Efficiency Through Centralized OrchestrationMilliporeSigma
Use this link to participate in the interactive on-demand webinar: http://bit.ly/Bio4COrchestrator
Detailed description:
In this talk, we discuss how orchestration software improves bioprocessing efficiency through the centralized configuration and management of connected unit operations for process and workflow automation across the plant floor.
A browser-based software solution, Bio4C™ Orchestrator software connects to individual unit operations from a centralized orchestration layer for remote access to systems, recipes, reports, user accounts and alarms from a holistic process dashboard.
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...Merck Life Sciences
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...MilliporeSigma
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPadMilliporeSigma
Watch the recording of this webinar here: https://bit.ly/2XFhqGj
Smart data management software, such as Bio4C™ ProcessPad, acquires data from disparate sources (paper records, spreadsheets, databases, LIMS, QMS, machine data) and automatically aggregates it into analysis-ready format for data visualization & analysis.
Now Bio4C™ ProcessPad’s advanced multivariate analytics capabilities enable quick identification of outlier batches within 100s of critical performance parameters and quality attributes and helps determine which process attributes are contributing to process variability.
Bio4C™ ProcessPad is a data visualization, advanced analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, ERP, MES, LIMS, Historians, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn about:
• Next generation bioprocessing and the BioContinuum™ Platform
• Bio4C™ ProcessPad data management software – capabilities around CPV, reporting, and process lifecycle management
• Statistical process control case studies - yield variability and instrument maintenance
• Advanced analytics (outlier detection using PCA and anomaly pattern search against historical data)
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPadMerck Life Sciences
Watch the recording of this webinar here: https://bit.ly/2XFhqGj
Smart data management software, such as Bio4C™ ProcessPad, acquires data from disparate sources (paper records, spreadsheets, databases, LIMS, QMS, machine data) and automatically aggregates it into analysis-ready format for data visualization & analysis.
Now Bio4C™ ProcessPad’s advanced multivariate analytics capabilities enable quick identification of outlier batches within 100s of critical performance parameters and quality attributes and helps determine which process attributes are contributing to process variability.
Bio4C™ ProcessPad is a data visualization, advanced analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, ERP, MES, LIMS, Historians, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn about:
• Next generation bioprocessing and the BioContinuum™ Platform
• Bio4C™ ProcessPad data management software – capabilities around CPV, reporting, and process lifecycle management
• Statistical process control case studies - yield variability and instrument maintenance
• Advanced analytics (outlier detection using PCA and anomaly pattern search against historical data)
Better Bioprocessing Efficiency Through Centralized OrchestrationMerck Life Sciences
Use this link to participate in the interactive on-demand webinar: http://bit.ly/Bio4COrchestrator
Detailed description:
In this talk, we discuss how orchestration software improves bioprocessing efficiency through the centralized configuration and management of connected unit operations for process and workflow automation across the plant floor.
A browser-based software solution, Bio4C™ Orchestrator software connects to individual unit operations from a centralized orchestration layer for remote access to systems, recipes, reports, user accounts and alarms from a holistic process dashboard.
Better Bioprocessing Efficiency Through Centralized OrchestrationMilliporeSigma
Use this link to participate in the interactive on-demand webinar: http://bit.ly/Bio4COrchestrator
Detailed description:
In this talk, we discuss how orchestration software improves bioprocessing efficiency through the centralized configuration and management of connected unit operations for process and workflow automation across the plant floor.
A browser-based software solution, Bio4C™ Orchestrator software connects to individual unit operations from a centralized orchestration layer for remote access to systems, recipes, reports, user accounts and alarms from a holistic process dashboard.
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...Merck Life Sciences
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...MilliporeSigma
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPadMilliporeSigma
Watch the recording of this webinar here: https://bit.ly/2XFhqGj
Smart data management software, such as Bio4C™ ProcessPad, acquires data from disparate sources (paper records, spreadsheets, databases, LIMS, QMS, machine data) and automatically aggregates it into analysis-ready format for data visualization & analysis.
Now Bio4C™ ProcessPad’s advanced multivariate analytics capabilities enable quick identification of outlier batches within 100s of critical performance parameters and quality attributes and helps determine which process attributes are contributing to process variability.
Bio4C™ ProcessPad is a data visualization, advanced analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, ERP, MES, LIMS, Historians, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn about:
• Next generation bioprocessing and the BioContinuum™ Platform
• Bio4C™ ProcessPad data management software – capabilities around CPV, reporting, and process lifecycle management
• Statistical process control case studies - yield variability and instrument maintenance
• Advanced analytics (outlier detection using PCA and anomaly pattern search against historical data)
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPadMerck Life Sciences
Watch the recording of this webinar here: https://bit.ly/2XFhqGj
Smart data management software, such as Bio4C™ ProcessPad, acquires data from disparate sources (paper records, spreadsheets, databases, LIMS, QMS, machine data) and automatically aggregates it into analysis-ready format for data visualization & analysis.
Now Bio4C™ ProcessPad’s advanced multivariate analytics capabilities enable quick identification of outlier batches within 100s of critical performance parameters and quality attributes and helps determine which process attributes are contributing to process variability.
Bio4C™ ProcessPad is a data visualization, advanced analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, ERP, MES, LIMS, Historians, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn about:
• Next generation bioprocessing and the BioContinuum™ Platform
• Bio4C™ ProcessPad data management software – capabilities around CPV, reporting, and process lifecycle management
• Statistical process control case studies - yield variability and instrument maintenance
• Advanced analytics (outlier detection using PCA and anomaly pattern search against historical data)
This presentation provides information on the SpiraPlan enterprise agile program management system from Inflectra. SpiraPlan lets you manage large-scale agile projects, programs and portfolios with integrated risk management, project planning, quality assurance, and resource management. Fully Integrated with end to end traceability and reporting.
This presentation provides information on the SpiraPlan enterprise agile program management system from Inflectra. SpiraPlan lets you manage large-scale agile projects, programs and portfolios with integrated risk management, project planning, quality assurance, and resource management. Fully Integrated with end to end traceability and reporting.
Manufacturing data requirements for supply chain origin, ingredients, and processes has in the past been applied primarily to food, beverage and pharmaceutical. Now, these requirements are being driven by regulatory agencies and the end user to ensure product safety in the automotive, life sciences and consumer packaged goods industry sectors.
An Integrated Simulation Tool Framework for Process Data ManagementCognizant
Digital simulations play an increasing role in product lifecycle management (PLM) processes and simulation data management (SDM) based on the PLM XML protocol, which is a key interface with computer-aided engineering (CAE) applications. We offer a framework for aligning SDM with the overall product development process to shorten lead times and optimize output.
Transforming Technology Transfer and Recipe Management: From Spreadsheets to ...guest070fdd
Presented by Paul Wlodarczyk at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
The creation and management of formulation and control recipes is a process that is overdue for transformation. Today, most pharmaceutical companies still rely on error-prone, manual recipe-management approaches, in which master recipes are treated as static and disconnected documents. These outdated approaches lead to delays in technology transfer and introduce errors as formulations are entered into execution and quality management systems. Inefficient technology transfer, in turn, leads to delays in commercialization, waste or poor yield, compliance challenges, and risks to product quality.
Recipe standardization and management can improve every aspect of the product lifecycle, from late-stage discovery through clinical and commercial manufacturing. As pharmaceutical companies increasingly implement Quality by Design principles, recipe standardization will ensure that critical process parameters and their ranges are documented in a uniform fashion, from the earliest phases of process development and then managed effectively through all stages of manufacturing.
This slide deck explores new approaches for standardizing recipe management to mitigate risk and accelerate time to market. You will see case studies and be provided with a framework for understanding how to migrate to standards-based recipe-management practices.
SSE Practices Overview covering systems engineering, embedded software development, DO178B/C, ISO 26262, IEC62304, and including some short exercises on practice customization
Company products need to comply with various standards, regulations or tracking guidelines to conduct business in any country. Compliance can slow down product launches into the desired markets and even act as a barrier to entry.
Rapidflow’s preconfigured Agile PG&C solution allows integrating substance information that is relevant to substance regulation into the Agile Product Lifecycle Management system in record time that makes this information immediately available to engineering, manufacturing, purchasing, quality, sales, and regulatory personnel and thereby ensuring product compliance.
This presentation on batch process analytics was given at Emerson Exchange, 2010. A overview of batch data analytics is presented and information provided on a field trail of on-line batch data analytics at the Lubrizol, Rouen, France plant.
Præsentation fra Jazz Roadshow 2011.
The value of integrated software delivery with
IBM Rational solution for
Collaborative Lifecycle Management.
Se mere fra IBM Softwaregroup på:
http://www.smarterbusiness.dk
Founded in 2010, we serve global leaders in the pharmaceutical, biopharmaceutical, biotechnology, medical devices, chemical, and food and beverage industries.
Our objective is to help organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective change management.
Visit us at: https://www.brevitas.us/
Putting the Ops in DataOps: Orchestrate the Flow of Data Across Data PipelinesDATAVERSITY
With the aid of any number of data management and processing tools, data flows through multiple on-prem and cloud storage locations before it’s delivered to business users. As a result, IT teams — including IT Ops, DataOps, and DevOps — are often overwhelmed by the complexity of creating a reliable data pipeline that includes the automation and observability they require.
The answer to this widespread problem is a centralized data pipeline orchestration solution.
Join Stonebranch’s Scott Davis, Global Vice President and Ravi Murugesan, Sr. Solution Engineer to learn how DataOps teams orchestrate their end-to-end data pipelines with a platform approach to managing automation.
Key Learnings:
- Discover how to orchestrate data pipelines across a hybrid IT environment (on-prem and cloud)
- Find out how DataOps teams are empowered with event-based triggers for real-time data flow
- See examples of reports, dashboards, and proactive alerts designed to help you reliably keep data flowing through your business — with the observability you require
- Discover how to replace clunky legacy approaches to streaming data in a multi-cloud environment
- See what’s possible with the Stonebranch Universal Automation Center (UAC)
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...MilliporeSigma
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process.
This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work.
Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
More Related Content
Similar to Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration
This presentation provides information on the SpiraPlan enterprise agile program management system from Inflectra. SpiraPlan lets you manage large-scale agile projects, programs and portfolios with integrated risk management, project planning, quality assurance, and resource management. Fully Integrated with end to end traceability and reporting.
This presentation provides information on the SpiraPlan enterprise agile program management system from Inflectra. SpiraPlan lets you manage large-scale agile projects, programs and portfolios with integrated risk management, project planning, quality assurance, and resource management. Fully Integrated with end to end traceability and reporting.
Manufacturing data requirements for supply chain origin, ingredients, and processes has in the past been applied primarily to food, beverage and pharmaceutical. Now, these requirements are being driven by regulatory agencies and the end user to ensure product safety in the automotive, life sciences and consumer packaged goods industry sectors.
An Integrated Simulation Tool Framework for Process Data ManagementCognizant
Digital simulations play an increasing role in product lifecycle management (PLM) processes and simulation data management (SDM) based on the PLM XML protocol, which is a key interface with computer-aided engineering (CAE) applications. We offer a framework for aligning SDM with the overall product development process to shorten lead times and optimize output.
Transforming Technology Transfer and Recipe Management: From Spreadsheets to ...guest070fdd
Presented by Paul Wlodarczyk at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
The creation and management of formulation and control recipes is a process that is overdue for transformation. Today, most pharmaceutical companies still rely on error-prone, manual recipe-management approaches, in which master recipes are treated as static and disconnected documents. These outdated approaches lead to delays in technology transfer and introduce errors as formulations are entered into execution and quality management systems. Inefficient technology transfer, in turn, leads to delays in commercialization, waste or poor yield, compliance challenges, and risks to product quality.
Recipe standardization and management can improve every aspect of the product lifecycle, from late-stage discovery through clinical and commercial manufacturing. As pharmaceutical companies increasingly implement Quality by Design principles, recipe standardization will ensure that critical process parameters and their ranges are documented in a uniform fashion, from the earliest phases of process development and then managed effectively through all stages of manufacturing.
This slide deck explores new approaches for standardizing recipe management to mitigate risk and accelerate time to market. You will see case studies and be provided with a framework for understanding how to migrate to standards-based recipe-management practices.
SSE Practices Overview covering systems engineering, embedded software development, DO178B/C, ISO 26262, IEC62304, and including some short exercises on practice customization
Company products need to comply with various standards, regulations or tracking guidelines to conduct business in any country. Compliance can slow down product launches into the desired markets and even act as a barrier to entry.
Rapidflow’s preconfigured Agile PG&C solution allows integrating substance information that is relevant to substance regulation into the Agile Product Lifecycle Management system in record time that makes this information immediately available to engineering, manufacturing, purchasing, quality, sales, and regulatory personnel and thereby ensuring product compliance.
This presentation on batch process analytics was given at Emerson Exchange, 2010. A overview of batch data analytics is presented and information provided on a field trail of on-line batch data analytics at the Lubrizol, Rouen, France plant.
Præsentation fra Jazz Roadshow 2011.
The value of integrated software delivery with
IBM Rational solution for
Collaborative Lifecycle Management.
Se mere fra IBM Softwaregroup på:
http://www.smarterbusiness.dk
Founded in 2010, we serve global leaders in the pharmaceutical, biopharmaceutical, biotechnology, medical devices, chemical, and food and beverage industries.
Our objective is to help organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective change management.
Visit us at: https://www.brevitas.us/
Putting the Ops in DataOps: Orchestrate the Flow of Data Across Data PipelinesDATAVERSITY
With the aid of any number of data management and processing tools, data flows through multiple on-prem and cloud storage locations before it’s delivered to business users. As a result, IT teams — including IT Ops, DataOps, and DevOps — are often overwhelmed by the complexity of creating a reliable data pipeline that includes the automation and observability they require.
The answer to this widespread problem is a centralized data pipeline orchestration solution.
Join Stonebranch’s Scott Davis, Global Vice President and Ravi Murugesan, Sr. Solution Engineer to learn how DataOps teams orchestrate their end-to-end data pipelines with a platform approach to managing automation.
Key Learnings:
- Discover how to orchestrate data pipelines across a hybrid IT environment (on-prem and cloud)
- Find out how DataOps teams are empowered with event-based triggers for real-time data flow
- See examples of reports, dashboards, and proactive alerts designed to help you reliably keep data flowing through your business — with the observability you require
- Discover how to replace clunky legacy approaches to streaming data in a multi-cloud environment
- See what’s possible with the Stonebranch Universal Automation Center (UAC)
Similar to Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration (20)
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...MilliporeSigma
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process.
This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work.
Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Use of Excipients in Downstream Processing to Improve Protein PurificationMilliporeSigma
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms.
This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.
Exploring the protein stabilizing capability of surfactants against agitation...MilliporeSigma
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase.
One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations.
Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms.
The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein F...MilliporeSigma
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection.
This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.
To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Characterization of monoclonal antibodies and Antibody drug conjugates by Sur...MilliporeSigma
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr
Highlights of this webinar:
- Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs.
- SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations.
- Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies.
- The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process
Detailed description:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life.
An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.
The Role of BioPhorum Extractables Data in the Effective Adoption of Single-U...MilliporeSigma
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization
This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study.
Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio
The Future of Pharma- and Biopharmaceutical AuditsMilliporeSigma
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...MilliporeSigma
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
Identity testing by NGS as a means of risk mitigation for viral gene therapiesMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3RijkHC
Detailed description:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.
The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources.
Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.
In this webinar, we'll explore:
• Regulatory requirements for identity testing
• NGS applications for identity testing as compared to traditional methods
• A case study on the impact of not establishing a proper risk-based testing strategy
Presented by: Bradley Hasson, Director of Lab Operations for NGS Services
Latest advancements of melt based 3D printing technologies for oral drug deli...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3A2WcH4
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.
Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented:
The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.
In this webinar, you will learn:
• Latest advancements of melt based 3D printing approaches
• Application examples for the individual technologies
• Deep dive in the MED® 3D printing technology to design dedicated drug release profiles
Presented by:
Dr. Thomas Kipping, Head of Drug Carriers
Dr. Xianghao Zuo, Deputy Director of R&D, Triastek
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
How does the ICH Q5A revision impact viral safety strategies for biologics?MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Insights from a Global Collaboration Accelerating Vaccine Development with an...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine.
In this webinar, you will learn:
• About building a priceless collaborative network with integrated solutions
• Virus-Like Particle Vaccines
• Process Development Overview and Challenges
• Pre-clinical Results and Next Steps
Presented by:
Jose M. Galarza, PhD,
President and Founder of TechnoVax
Naomi Baer,
Business development consultant, Emerging Biotech, BioProcess division
Youssef Gaabouri, Eng. ,
Associate Director, Head of Sales Middle East & Africa, BioProcess division
Risk-Based Qualification of X-Ray Sterilization for Single-Use SystemsMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3vQf0qv
In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods.
The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods.
In this webinar, you will learn about:
• The comparison of gamma and X-ray irradiation sterilization
• A risk-based qualification test strategy
• Data evaluation of gamma versus X-ray sterilized single-use components
Presented by:
Monica Cardona,
Global Senior Program Manager
Paul Killian, Ph.D.,
R&D Director, Analytical Technologies
Rapid Replication Competent Adenovirus (rRCA) Detection: Accelerate your Lot ...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
• Regulatory framework for adenoviral vector products
• Considerations for lot release testing of adenoviral-based therapies
• Advantages of a rapid method for RCA testing on production lot material
Presented by:
Axel Fun, Ph.D.,
Principal Scientist
Alberto Santana, MBA,
Product Manager, Biologics Biosafety Testing
The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K
Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations.
Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
• excellent sugar-like taste profile
• outstanding sweetness factors
• use effectiveness
• enhanced stability
We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception.
In this webinar, you will learn:
• How to optimize the patients' taste experience of your pharmaceuticals
• How sweeteners can be differentiated by their sensory profiles and features
• How our new product offering Neotame can be effectively used in your targeted formulations
Presented by:
Almut von der Brelie,
Senior Manager Strategic Marketing, Excipients for Solid Applications
The Developability Classification System (DCS): Enabling an Optimized Approac...MilliporeSigma
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS).
The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed.
#solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment
How to Accelerate and Enhance ADC TherapiesMilliporeSigma
In this webinar, you will learn about:
The advantages of using advanced intermediates to develop ADC therapies
How to increase ADC solubility and efficiency
Fast, small-scale ADC library generation
Seamless supply chain with reduced complexity and regulatory support
The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window.
Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.
EU GMP Annex 1 Draft - Closed System Design Consideration with Single-Use Sys...MilliporeSigma
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. Please attend the webinar to learn more!
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
We understand the unique challenges pickleball players face and are committed to helping you stay healthy and active. In this presentation, we’ll explore the three most common pickleball injuries and provide strategies for prevention and treatment.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
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CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
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Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration
1. The life science business of Merck KGaA,
Darmstadt, Germany operates as
MilliporeSigma in the U.S. and Canada.
Improve Operational Efficiency
by Over 30%
with Product, Process, & Systems
Agnostic Orchestration
Braj Nandan Thakur
24th May 2022
2. The Life Science business of
Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma in the
U.S. and Canada.
3. Agenda
1
2
3
Automation Strategy and Technology Alternatives
What’s a Product, Process, and System Agnostics Platform?
4
5
Key Considerations for Automation in Biopharma
Process Orchestration Software Benefits
Summary
4. Choices for Automation & Digital Platform
Key considerations
4
Reduce Cost
Time to Market
Quality & Compliance
Current business challenge & future readiness
Operator-experiential
decision making
Product, Process & Systems
Oriented Automation
Product, Process & Systems
Agnostics Automation
Digital &
Automation Choice
Data-driven
decision making
Digital & Automation Platform
Plan Prepare Execute Test Release
Customized Solution OOB, Configurable & flexible
Solution
Digital &
Automation Choice
Traditional Industrial Automation Purpose built automation
Digital &
Automation Choice
BIG BANG-Project Complexity &
Managing Risk
Digital &
Automation Choice
Phased approach-Project
Complexity & Managing Risk
5. Setting the context for an agnostic automation platform
Traditional Automation Approach Shortcomings
SENSORS AND ACTUATORS/ HARDWARE
PLC/LOCAL
CONTROLS
STANDARD INDUSTRY OFFERINGS
MES
DCS/
SUPERVISORY
CONTROLS
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
5
* DPMM – BioPhorum’s Digital Plant Maturity Model
Pre-Digital Plant
✓ Paper-Based
✓ Manual processes
✓ Isolated Unit operations
Digital Siloes
✓ Islands of automation
✓ Recipes on systems
✓ Offline analytics
Connected Plant/
Predictive Plant
✓ Vertically integrated
systems
✓ Automated data
analytics
✓ Processing Modeling
& Monitoring
Fully Digital Adaptive
✓ Predictive analytics
✓ “Plug and Play”
Automation
✓ Continuous process
verification
Digital Transformation Journey
6. A lean approach towards automation with of connectivity, workflow,
and integration layers
Product, Process, and System Agnostic Platform
Minimize risk, maximize value, and be future ready with product and process agnostic automation platform
ERP/Planning tools
BMR
Workflow Layer
Integration layer
QC-LIMS
ERP/Planning tools
Inventory
Management
Connectivity Layer
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
6
Plan Prepare Execute Test Release
7. Building blocks of the solution
Product, Process and System Agnostic platform
Connect Workflow Integration
Data management platform to support data-driven decision making and enable Bioprocessing 4.0
Connector library/standard protocol
provides OOB, vendor-agnostic solution
Template library permits flexible building of
product- and process-agnostic workflows
Results into batch reports, integrated data
layer to facilitate analytics, BMR execution
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
7
8. Start simply yet effectively; realize quick value and evolve for future needs
Bio4C Orchestrator™ Software
After
Before
Plan Execute Test - Data Analysis &
Report, Review &
approval
Prepare Release
Plan Execute Test - Data
Analysis & Report,
review & approval
Prepare
Release
Managing non-value add alarm, status, monitoring, manual data capture, review and approval
would compress the batch release cycle time substantially
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
8
9. 9
A design philosophy aligned with the BioPhorum's Technology Roadmap
Lean and Agile
Digital Platform
Extendibility
STANDARD
EASE OF USE
FLEXIBILITY
MODULARITY
INTER-
OPERABILITY
FUTURE
READINESS
?
?
?
Continuous
BATCH
Designed considering next generation of bioprocessing
A Better Approach for Bioprocessing
10. SENSORS AND ACTUATORS/
HARDWARE
PLC/LOCAL
CONTROLS
Bio4C Orchestrator™
3rd PARTY Systems
connectivity
Remote
Support
Reporting
User Management
Process Trend-Monitoring &
Visualization
Data Storage &
back up
Recipe
Management
Advanced
Analytics
STANDARD INDUSTRY OFFERINGS
DCS/
SUPERVISORY
CONTROLS
MES
Bio4C Orchestrator™ Software
Where Bio4C Orchestrator™ Software fits within industry offerings
10
FOCUS ON BIOMANUFACTURING OPERATIONAL NEEDS
Bio4C Orchestrator™ Software
11. Realize value in < 3 months
Bio4C Orchestrator™ Software
Title of Presentation | DD.MM.YYYY
11
Advance your bioprocessing operations from Islands of Automation to a Connected Plant
1
2
3
4
6
5
Bio4C
Orches-
trator
Modern, Modular, Flexible
Connectivity Ecosystem
Process/Plant
Data Layer
Effective Data Management
Operational
Capabilities
Centralized Monitoring
& Visualization
12. 12
Process Monitoring
Equipment information
Systems status
Easily connect and disconnect
Alarm status
Recipe run status
Enhanced visibility, collaboration and timely action
Monitor systems in multiple remote locations
13. 13
Process Monitoring
Live trending for all connected systems
Live trending of any system
Select and monitor specific
parameters from a system
Create user preferred views
Compare and overlay trends
across connected skids
15. Reporting
15
Content rich reports
Centralized reporting simplifies data gathering
Batch and time-based reporting
Configurable report templates
Full audit trails
Report approvals with E-
signatures
Reports include
Pre runs setpoints
Manual event report
Alarm event report
Security report
Recipe step reports
Trends configuration
included in reports
16. 16
User Management
Remotely manage roles and permissions from a central dashboard
Significantly reduces time & effort to manage users in the
connected plant
• Administrator can assign and
unassign roles
• Users are synced to the Systems
• Users can be de-activated
• Supports User Catalog/Active
Directory Integration
• Can Create and Manage Custom
roles and Permissions
17. M Lab™ Global Rollout with 7 sites across the globe
Bio4C™ Orchestrator™ Software
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
17