This webinar will highlight different barcode types, regulations and standards applied to 2D barcodes in the industry, as well as applications and advantages of 2D Data Matrix barcodes.
Digital technologies offer new opportunities to provide and exchange information between raw material suppliers and their customers. While accessing product-related data for different raw materials and devices is essential, it can be a cumbersome task in the pharmaceutical quality and production processes. Often, data processing is required at many steps and must be done manually, which is time consuming and a source for potential errors. 2D Data Matrix barcodes offer a seamless and robust solution for data management, internal processes and inventory management challenges.
In this webinar, you will learn:
• Overview of different barcode types
• Regulations and standards applied to 2D barcodes in the industry
• Applications and advantages of 2D Data Matrix barcodes
RFID F2F Anuga FoodTec 2012 - Speakers' Corner: RFID and WSN for food traceab...Marco Battistella
Farm to Fork is an open transnational food information framework which allows customers purchasing food products to access traceability information about the product.
Professor Robert Newman, from the University of Wolverhampton’s School of Technology (Project Coordinator), presented the RFID F2F project, that aims at showcasing to SMEs the benefits of Radio-frequency Identification from the producer to the consumer.
Apart from the presentation of the system, two categories have been addressed and presented to the audience with focus on the cheese and meat pilots deployed by University of Wolverhampton, Piero Filippin.
Counterfeit is a problem of product security.
A counterfeit product is an imitation which infringes upon a production monopoly held by either a state or corporation.
Infringing products are being produced and consumed in virtually all economies.
Counterfeiters and pirates target products where profit margins are high, taking into account the risks of detection, the potential penalties, the size of the markets that could be exploited and the technological and logistical challenges in producing and distributing products.
Pharma duplication remains the biggest area of concern as it is facing the highest level of threat and the consumer of pharmaceuticals products are the worst sufferers.
The international community is at a cross-roads, keep allowing counterfeit medicinal drugs, or create legislation that prevents that from happening in the future. The legislation has been created, so how will you ensure compliance?
In fast-paced mass manufacturing, every product needs to be identified for traceability to avoid the slipping of faulty products into the hands of consumers.
There are many different barcodes to choose from, and that make it impossible to implement a barcoding solution. In our latest series we are discussing everything that you need to know about barcoding solutions.
RFID F2F Anuga FoodTec 2012 - Speakers' Corner: RFID and WSN for food traceab...Marco Battistella
Farm to Fork is an open transnational food information framework which allows customers purchasing food products to access traceability information about the product.
Professor Robert Newman, from the University of Wolverhampton’s School of Technology (Project Coordinator), presented the RFID F2F project, that aims at showcasing to SMEs the benefits of Radio-frequency Identification from the producer to the consumer.
Apart from the presentation of the system, two categories have been addressed and presented to the audience with focus on the cheese and meat pilots deployed by University of Wolverhampton, Piero Filippin.
Counterfeit is a problem of product security.
A counterfeit product is an imitation which infringes upon a production monopoly held by either a state or corporation.
Infringing products are being produced and consumed in virtually all economies.
Counterfeiters and pirates target products where profit margins are high, taking into account the risks of detection, the potential penalties, the size of the markets that could be exploited and the technological and logistical challenges in producing and distributing products.
Pharma duplication remains the biggest area of concern as it is facing the highest level of threat and the consumer of pharmaceuticals products are the worst sufferers.
The international community is at a cross-roads, keep allowing counterfeit medicinal drugs, or create legislation that prevents that from happening in the future. The legislation has been created, so how will you ensure compliance?
In fast-paced mass manufacturing, every product needs to be identified for traceability to avoid the slipping of faulty products into the hands of consumers.
There are many different barcodes to choose from, and that make it impossible to implement a barcoding solution. In our latest series we are discussing everything that you need to know about barcoding solutions.
This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Barcode or Barcode Reader is an optical machine-readable representation of data relating to
the object to which it is attached. Originally barcodes systematically represented data by varying
the widths and spacing of parallel lines, and may be referred to as linear or one-dimensional
(1D). Later they evolved into rectangles, dots, hexagons and other geometric patterns in two
dimensions (2D). Although 2D systems use a variety of symbols, they are generally referred to
as barcodes as well. A barcode reader uses a photo sensor to convert the barcode into an
electrical signal as it moves across a barcode. Mechanism: The scanner then measures the
relative widths of the bars and spaces, translates the different patterns back into regular
characters, and sends them on to a computer or portable terminal. If we use barcodes, we get
online information without giving any data to the computer. If the manufacturing company
produces large quantity of products, then these barcodes are very useful.
Ignite 2015 Stefan Artlich - To Each Drug Package its Own Unique Number - Is ...Elemica
Stefan Artlich, Dir. Product Tracking and Authentication at Bayer Tech, focuses on how to develop and execute implementation roadmaps for pharmaceutical track-and-trace and how companies can comply regulations through better data capture and supply chain visibility gained from a business network.
The increasing number of product recalls, concerns about bioterrorism, product counterfeit, contamination and foodborne illness outbreaks have forced the need to greater product traceability throughout the supply chain. Using today's information technology tools can enable businesses to respond more quickly and accurately, saving time, labor and in some cases, lives. Product recalls are costly. Companies that do not use traceability technology tools rely on manual methods of tracking products and often end up destroying large quantities of goods just to make sure that all affected products are identified and captured. Using technology to track and trace goods through the supply chain is much more accurate and can provide additional benefits. Traceability tools can provide an array of valuable data that can be used to improve business and operational processes. Governmental regulations such as those of the United States and European Union require some level of product traceability for food products. Traceability solutions can help with documentation and recordkeeping, safety monitoring, enabling process improvements and better decision making and much more. Traceability technology tools include product identification and marking tools, traceability software and RFID. Of these, product identification and marking tools are the most commonly used. Product identification tools include barcode and imprinting tools that rely on tracking numbers to connect production history data with that of the finished goods. Traceability, or track and trace software may be best-of-breed software solutions or functionality within warehouse management software (such as Datex FootPrint WMS). Having software that provides track and trace functionality including the collection and retention of data, documentation of processes, etc. is extremely important when dealing with regulated goods such as food and pharmaceuticals. Using traceability software or a WMS with track and trace capabilities, audit trail etc. can help meet the documentation requirements of FDA and other government agency regulations. Using software with traceability capabilities can also enable your business to compete more successfully to win the business of retailers. Today, retailers often require EDI (Electronic Data Interchange) as well as immediate product recall action within a few hours. Using advanced software and systems can provide these necessary capabilities.
"The Barcode" Presentation
By: Group Four (Aslam, Ceren, Fohn, Sara and Youssef)
for the group assignment of the "Research Methodology" course at the University of Greenwich
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
FREYR UDI VISION SERIES SESSION 1 - UDI READINESSFreyr Solutions
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.
Topics covered include:
• What is RFID?
• Item identification - Barcode or RFID?
• ecom RFID portfolio
• How and where can I use RFID?
• What are the advantages and benefi ts of RFID?
What is UPC Code? What Are Types Of UPC Codes?
A UPC is a form of code that is placed on retail goods packaging to help identify a specific item.
It is made up of two parts: the machine-readable barcode (a series of unique black bars) and the distinctive 12-digit number beneath it.
Types of UPC codes
See more: https://barcodelive.org/what-is-upc-codes
Through practical case studies and industry specific analysis sessions, Medical Device UDIs & Traceability Forum Europe 2015 is geared around strengthening your regulatory infrastructure, maintaining productivity and ensuring ROI from your UDI projects.
View the full agenda here: bit.ly/MedicalDeviceUDI2015Agenda
Alternatively, email enquire@iqpc.co.uk or call +44 (0)207 036 1300 for a copy.
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...Merck Life Sciences
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 Smart Labels - Digital Innovation by Raw Material Suppliers to Support Drug Manufacturers’ Processes
This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Barcode or Barcode Reader is an optical machine-readable representation of data relating to
the object to which it is attached. Originally barcodes systematically represented data by varying
the widths and spacing of parallel lines, and may be referred to as linear or one-dimensional
(1D). Later they evolved into rectangles, dots, hexagons and other geometric patterns in two
dimensions (2D). Although 2D systems use a variety of symbols, they are generally referred to
as barcodes as well. A barcode reader uses a photo sensor to convert the barcode into an
electrical signal as it moves across a barcode. Mechanism: The scanner then measures the
relative widths of the bars and spaces, translates the different patterns back into regular
characters, and sends them on to a computer or portable terminal. If we use barcodes, we get
online information without giving any data to the computer. If the manufacturing company
produces large quantity of products, then these barcodes are very useful.
Ignite 2015 Stefan Artlich - To Each Drug Package its Own Unique Number - Is ...Elemica
Stefan Artlich, Dir. Product Tracking and Authentication at Bayer Tech, focuses on how to develop and execute implementation roadmaps for pharmaceutical track-and-trace and how companies can comply regulations through better data capture and supply chain visibility gained from a business network.
The increasing number of product recalls, concerns about bioterrorism, product counterfeit, contamination and foodborne illness outbreaks have forced the need to greater product traceability throughout the supply chain. Using today's information technology tools can enable businesses to respond more quickly and accurately, saving time, labor and in some cases, lives. Product recalls are costly. Companies that do not use traceability technology tools rely on manual methods of tracking products and often end up destroying large quantities of goods just to make sure that all affected products are identified and captured. Using technology to track and trace goods through the supply chain is much more accurate and can provide additional benefits. Traceability tools can provide an array of valuable data that can be used to improve business and operational processes. Governmental regulations such as those of the United States and European Union require some level of product traceability for food products. Traceability solutions can help with documentation and recordkeeping, safety monitoring, enabling process improvements and better decision making and much more. Traceability technology tools include product identification and marking tools, traceability software and RFID. Of these, product identification and marking tools are the most commonly used. Product identification tools include barcode and imprinting tools that rely on tracking numbers to connect production history data with that of the finished goods. Traceability, or track and trace software may be best-of-breed software solutions or functionality within warehouse management software (such as Datex FootPrint WMS). Having software that provides track and trace functionality including the collection and retention of data, documentation of processes, etc. is extremely important when dealing with regulated goods such as food and pharmaceuticals. Using traceability software or a WMS with track and trace capabilities, audit trail etc. can help meet the documentation requirements of FDA and other government agency regulations. Using software with traceability capabilities can also enable your business to compete more successfully to win the business of retailers. Today, retailers often require EDI (Electronic Data Interchange) as well as immediate product recall action within a few hours. Using advanced software and systems can provide these necessary capabilities.
"The Barcode" Presentation
By: Group Four (Aslam, Ceren, Fohn, Sara and Youssef)
for the group assignment of the "Research Methodology" course at the University of Greenwich
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
FREYR UDI VISION SERIES SESSION 1 - UDI READINESSFreyr Solutions
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.
Topics covered include:
• What is RFID?
• Item identification - Barcode or RFID?
• ecom RFID portfolio
• How and where can I use RFID?
• What are the advantages and benefi ts of RFID?
What is UPC Code? What Are Types Of UPC Codes?
A UPC is a form of code that is placed on retail goods packaging to help identify a specific item.
It is made up of two parts: the machine-readable barcode (a series of unique black bars) and the distinctive 12-digit number beneath it.
Types of UPC codes
See more: https://barcodelive.org/what-is-upc-codes
Through practical case studies and industry specific analysis sessions, Medical Device UDIs & Traceability Forum Europe 2015 is geared around strengthening your regulatory infrastructure, maintaining productivity and ensuring ROI from your UDI projects.
View the full agenda here: bit.ly/MedicalDeviceUDI2015Agenda
Alternatively, email enquire@iqpc.co.uk or call +44 (0)207 036 1300 for a copy.
Similar to Smart Labels - Digital Innovation by Raw Material Suppliers to Support Drug Manufacturers’ Processes (20)
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...Merck Life Sciences
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 PurificationMerck Life Sciences
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...Merck Life Sciences
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...Merck Life Sciences
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...Merck Life Sciences
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...Merck Life Sciences
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
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...Merck Life Sciences
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 therapiesMerck Life Sciences
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...Merck Life Sciences
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...Merck Life Sciences
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
Viral safety of biologics: What's changing with the ICH Q5A revision?Merck Life Sciences
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
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...Merck Life Sciences
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
Insights from a Global Collaboration Accelerating Vaccine Development with an...Merck Life Sciences
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 SystemsMerck Life Sciences
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 ...Merck Life Sciences
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...Merck Life Sciences
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...Merck Life Sciences
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
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.
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
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.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
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.
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
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.
Performance Standards for Antimicrobial Susceptibility Testing
Smart Labels - Digital Innovation by Raw Material Suppliers to Support Drug Manufacturers’ Processes
1. Merck KGaA
Darmstadt, Germany
Dr. Philipp Buehle
Digital innovation by raw material suppliers to support
drug manufacturers’ processes
Smart Labels
2. 2 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
The life science business of
Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma
in the U.S. and Canada.
3. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes3
Agenda
Barcode – Definition, types and background
Regulations and standards applied to 2D barcodes in the industry
Applications and advantages of 2D Data Matrix barcodes
Company Example - Scan Now Page
Summary
Introduction
4. Barcodes are everywhere in our daily lives
4 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
Smart Labels
5. Smart Labels
Barcodes are everywhere in our daily lives
5 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
• Easy and reliable data transfer – e.g. Laboratory samples
• Control of processes – e.g. Board pass, luggage
• Registration processes – e.g. Identifying a cow
• Prevent permutation – e.g. Baby
• Logistic processes – e.g. Parcel distribution
6. Smart Labels
Barcodes in pharmaceutical processes?
Do you want to avoid manual,
time-consuming data
processing and sources for
potential errors?
Is accessing product-related
data for raw materials and
devices a cumbersome task
in your pharmaceutical
production process?
6 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
7. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes7
Agenda
Barcode – Definition, types and background
Regulations and standards applied to 2D barcodes in the industry
Applications and advantages of 2D Data Matrix barcodes
Company Example - Scan Now Page
Summary
Introduction
8. Barcode – History Review
1
9
7
3
Firstexperim
ents
started
at
D
rexel
University/Philadelphia
UPC-code
introduced
in
U.S.
1st
EAN
-code
introduced
in
Europe
1
9
4
9
1
9
7
41
9
7
6
1st
barcodes
scanned
at
W
alm
art
8 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
EAN
Association
as
precursor
ofG
S
starts
1
9
7
7
1st
PD
F417
code
1
9
9
3
1st
D
ata
M
atrix
barcode
First
ISO
barcode
guidelines
1st
Q
R-code
1
9
9
1
1
9
8
9
1
9
9
4
2
0
1
7
O
ur
Sm
art
Labels
project
w
as
launched
UD
I
becom
es
m
andatory
w
ithin
EU
EU
Regulation
Falsified
m
edicine
m
andatory
FD
A-UD
I
for
class
I
devices
m
andatory
2
0
2
0
s
2
0
2
0
2
0
1
9
Smart Labels
9. Barcode Definition and Types
• More than 30 different 1D
barcodes types
• Most common ones:
• Code-128 mostly as
GS-128
• Universal Product Code
(UPC-A)
• European Article
Number 13 (EAN-13)
Linear or
1D Barcodes
1
EAN-13
UPC-A
• Also more than 30
different 2D barcode
types!
• Stapled and Matrix types
are the most important
categories
• Codablock (Types A, F,
256)
• Portable Data File
(PDF417)
2D Barcodes2 3 Stapled Codes
PDF417
• Aztec-Code
• Quick-Response-Code
(QR-Code)
• Data Matrix Code (DMC)
4 Matrix Codes
DMC
QRAztec
Optically coded and machine readable data that can be 1-dimensional (1D) or 2-dimensional (2D)
9
(01)04027269077082
EAN-13
Codablock F
10. Barcode Characteristics I
10 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
• Limited length by reader
(Full ASCII character set)
• Used for shipping and
packaging industries
• Worldwide
• Part of GS1 standard
• Error correction by 2 characters
• 13 digit code (numeric only)
• Used for retail and grocery
• Worldwide
• Part of GS1 standard
• Error Correction by final check
digit
• 12 digit code (numeric only)
• Used for retail and grocery
• USA, CAN, UK, AUS, NZ
• Part of GS1 standard
• Error correction by final check
digit
• 2725 ASCII or 5450 numeric
characters
• Healthcare sample management
• EU
• Not part of GS1 standard
• Error Correction by check sum
CodablockEAN-13
(01)04027269077082
UPC-A
GS-128
- Error Correction
11. Barcode Characteristics II
11 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
• 1850 alphanumerical, 2725
numeric characters
• Used for boarding passes, driving
licenses
• Worldwide
• Not part of GS1 standard
• Error Correction by Reed
Solomon
• 7089 numeric or 4296 ASCII
characters
• Used for mobile applications,
marketing links, …
• Worldwide
• Part of GS1 standard
• Error Correction by Reed
Solomon
• 3832 numeric, 3067 ASCII
characters
• Used for railroad ticketing
• Worldwide
• Not part of GS1 standard
• Error Correction by Reed
Solomon
• 3116 numeric or 2335 ASCII
characters
• Used for UDI, drug products
• Worldwide
• Part of GS1 standard
• Error Correction by Reed
Solomon
QR Codes
Aztec
Data Matrix
PDF417
- Error Correction
12. Smart Labels
RFID vs. Data Matrix 2D Barcode
12 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
Radio-Frequency Identification (RFID) Data Matrix barcode
Costs per label unit 5-10 ct Only some ink
Cost per scanning point 1000-5000 € 40-1000 €
Data volume 10.000 bit and more 3116 numeric characters
2335 ASCII characters
Security Re-writable RFID chips might be falsified Can not be changed after printing
process
Flexibility in chemical/
pharmaceutical
industry
- PE vs. metal packaging needs different RFID
chips
- Restricted in ex-zone areas
- No restrictions of package material
- Ex-zone scanners already
available
Scanning distance 1 to 3 m - no direct visibility needed Up to 21 m – direct visibility needed
Scans per “shot” 40-200 1 per scan
Standardization GS1 & ISO standards: Yes,
but frequencies are not globally harmonized
GS1 & ISO standards: Yes
13. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes13
Agenda
Barcode – Definition, types and background
Regulations and standards applied to 2D barcodes in the industry
Applications and advantages of 2D Data Matrix barcodes
Company Example - Scan Now Page
Summary
Introduction
14. U.S.-FDA
- National Drug Code (NDC) - 21 CFR 201.25: “Bar code label requirements”
•“NDC number in a linear bar code that meets EAN/Uniform Code Council (EAN.UCC) or Health
Industry Business Communications Council (HIBCC) standards.”
•Needed on drug product packages but not on API labels.
- Drug Supply Chain Security Act (DSCSA)
•Includes the 2D data matrix code as an option to secure the supply chain of a drug.
Conclusion: So far U.S.-FDA requests no 2D barcodes for serialization of packages.
Barcode-related regulations
U.S.-FDA & EU regulations
14 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
15. Goal of EU directive “Falsified Medicine Directive” (2011/62/EU)
•Preventing and managing risks posed by counterfeit/falsified medicines
EU requirements
•Implementation plan EMA/785582/2014 rev.2 / June 29, 2017:
• Deadline for existing products: February 19, 2019
•Implementation is done by a Data Matrix 2D barcode
•NEW - Serialization of each package within the barcode
Barcode-related regulations
U.S.-FDA & EU regulations
15 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
16. Barcode-related regulations
Unique Device Identification (UDI) in the EU & U.S.-FDA
16 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
• EU: Improve safety of patients through better transparency
and traceability
• U.S.-FDA: Identify medical devices through distribution & use
On high level EU and U.S.-FDA regulations are quite similar
• EU: Medical devices (2017/745) and in IVDs (2017/746)
• U.S.-FDA: 21 CFR 801 Subpart B
• EU: Depending in product type and specific classes
between 2023 and 2027.
• U.S.-FDA: 2020 for Class I (latest)
• Unique Device Identification of medical device products and
in-vitro diagnostics (IVDs)
17. Smart Labels
Barcode related regulations – UDI in the EU & FDA
17 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
• Device Identifier (DI) which identifies labeler and specific
version or model of a device
• e.g. Global Trade Item Number (GTIN) issued by GS1
• GS1 is an U.S.-FDA-accredited issuing agency
• Production Identifier(s) (PI)
• e.g. by lot number, batch or serial number and expiration
or manufacture date
• Data carrier (2D Data Matrix Barcode)
• Human Readable Interpretation
(1-to-1 illustration of the encoded data)
• 2D Data Matrix barcode incl. GS1 standard
18. Smart Labels
Barcode related regulations – UDI in the EU & FDA
18 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
• Provide device specific data (DI) and related key data
Aside from some details, requirements are the same
• U.S.-FDA database: GUDID (already active)
• EU database for medical devices and IVDs: EUDAMED
• Manufacturers, authorized representatives, importers and
distributors must track information related to medicinal devices
• U.S.-FDA & EU ask for a complete data traceability provided
by a 2D Data Matrix barcode
19. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes19
Agenda
Barcode – Definition, types and background
Regulations and standards applied to 2D barcodes in the industry
Applications and advantages of 2D Data Matrix barcodes
Company Example - Scan Now Page
Summary
Introduction
20. Smart Labels
Reed Solomon Error Correction
20 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
• Consumer technologies: CDs, DVDs, Blu-ray Discs
• Barcodes: PDF417, Aztec, QR, Data Matrix
• DSL (Internet), DVB (Television), RAID 6 (Data storage)
• Introduced in the 1960s by I. Reed and G. Solomon at MIT
Lincoln Laboratory
• 1st
application during NASA Voyager program in 1977
• Non-binary cyclic error-correcting code
• Can detect multiple symbol errors up to 30%
21. “GS1 - The Global Language of Business”
•A worldwide not-for-profit organization located in over 100 countries.
Originated by fusion of EAN International (EU) and Uniform Code Council (U.S.).
•Goal: Develop and maintain global standards as language for business communication.
•They offer standards for:
• Identification – by globally unique identification keys – e.g. Global Trade Item Number (GTIN)
• Capture – Definitions for 1D & 2D barcodes and radio-frequency identification (RFID) data carriers
by GS1 Application Identifiers (AI)
• Share – Exchange of business-critical information – e.g. product master data
• Use – Streamlining business processes – e.g. traceability
More than 20 GS1 standards in place.
•Applications:
• Retail industry is dominated by the GS1 system.
• Within healthcare e.g. falsified medicine prevention.
Smart Labels
Global Standard One - GS1
21 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
22. Smart Labels
22 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
1
EAN & GTIN are global @GS1 registered
unique trade numbers specific for each
product package.
2
3
!
EAN is the older 13 digit version, e.g.
used in 1D barcodes on our chemicals
product labels.
GTIN is the newer 14 digit number and
is required for 2D Data Matrix barcodes
following GS1.
GTIN is mandatory for leading digital
e-commerce platforms.
Global Trade Item Number - GTIN
23. GTIN example for Catalog Number 1.02367.9029:
04027269077082
Smart Labels
Global Trade Item Number (GTIN) Structure: Company Example
23 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
• GTIN tells you that it is a product from our company
• Identification & verification of a specific product package
Data Sections Content
0
Indicator digit converts a 13 digit EAN into a 14 digit GTIN without
changing the check digit 2
4027269 GCP (Global Company prefix) stands for our company
07708 7708th
of 100.000 items which can be registered under one GCP
2 Check digit
24. Falsified Medicine
DMCs are used to clearly
identify medicinal products
Smart Labels
Give access to product data
and related data
UDI
DMCs mark and identify
medical devices within the
healthcare supply chain
Smart Labels
The Data Matrix 2D barcode - One platform to improve processes
FM
UDI
SL
24 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
25. Smart Labels
Conclusion: Why a Data Matrix 2D Barcode incl. GS1?
Data
Matrix 2D
barcode
Global
Standard
One (GS1)
Error
correction
up to 30%
Established in
pharmaceutical
industry
• Defined by
ISO/IEC
16022:2006
• Product data can
be incorporated
• Industry standard
• Application Identifier
Codes compatible to
a broad range of
electronic systems
• ECC200 Reed-
Solomon Error
Correction is used
• More robust
against specular
reflection
or degradation of
the barcode
Authorities:
•UDI regulations
•Falsified medicine
directive
25 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes25
26. Smart Labels
Direct Data Transfer Into Customer Systems
not for use
0104027269077082111712001519123110A12369672401023679029422276
GS1 Application
Identifier Codes
01: Global Trade Item Number
11: Manufacturing Date
15: Expiration Date
10: Lot/Batch Number
240: Item Number
422: Country of Origin
26 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
Barcode data will
remain human
readable on
labels
27. Direct data transfer: SAP example
27 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
0104027269077082111712001519123110A12369672401023679029422276
Smart Labels
Distribute data content directly into pre-
defined fields within SAP by GS1 AIs
28. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes28
Agenda
Barcode – Definition, types and background
Regulations and standards applied to 2D barcodes in the industry
Applications and advantages of 2D Data Matrix barcodes
Company Example - Scan Now Page
Summary
Introduction
29. Smart Labels
From Label to Scan Now
29 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
30. Copy to clipboard for
easy data access
Smart Labels
From Scan Now to Product Data
30 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
31. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes31
Agenda
Barcode – Definition, types and background
Regulations and standards applied to 2D barcodes in the industry
Applications and advantages of 2D Data Matrix barcodes
Company Example - Scan Now Page
Summary
Introduction
32. 32 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
Smart Labels
Summary – Smart Labels
• For the entire Life Science portfolio
• Data matrix 2D barcode type
• GS1 as global standard
• Product data within 2D barcode
33. • Falsified Medicine and UDI regulations build regulatory framework for
2D Data Matrix Barcode
• GS1 Standard supports global use in various tools
• Increased robustness through Reed Solomon error correction
• Smart Labels provide standardized data access and data transfer
Smart Labels
Summary – 2D Data Matrix Barcode
33 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
34. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes34
How can barcodes help you to increase efficiency and reliability?
Smart Labels
Convenient master data handling
More reliable data input into systems
Fast access to product documents
Verification of incoming goods and
within supply chain processes