This product guide covers the basics of Millipak® Final Fill Filters. Learn how to maximize product recovery and enhance protection of your high value product.
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
This product guide covers the basics of Millipak® Final Fill Filters. Learn how to maximize product recovery and enhance protection of your high value product.
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
Potential Impact of Draft Annex 1 on Sterilizing FiltrationMilliporeSigma
Access the interactive recording here: https://bit.ly/2mvFxs7
Abstract:
The support for EMA GMPs related to sterile medicinal products is Annex 1. EMA, PICS and WHO have collaborated on the largest and most comprehensive revision of Annex 1 since it was first written in 1997.
There are a number of proposed changes to the sections in Annex 1 dealing with filtration, integrity testing and single-use.
This presentation will compare the current version with the proposed changes and highlight areas of specific interest to companies who either manufacture in or export to EMA countries, PICS member countries, and WHO compliant countries.
In This PPT Various Equipments Used In Pharma Industry Are Discussed. It can Be Used As Source Of Knowledge For Studnets Who Want To Gain Knowledge Other Than Books.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the quality control tests of parenteral as referred in the pharmacopoeia.
Thank you for reading. Hope it was of help to you.
UIPS,PU team
Rapid sterility testing system is an automated solution for the rapid detection, response, and resolution of microbial contamination in filterable samples throughout the manufacturing process. Accurate, rapid sterility testing is not only critical for patient safety it also makes great sense for the compounders and other pharmaceutical manufacturers.
STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATIONAVIJIT BAKSHI
PRESENTATION CONTAINS THE INFORMATION ABOUT STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATION FOLLOWED BY PHARMACEUTICAL MANUFACTURING COMPANIES.
Endotoxin Control and Clearance in BiomanufacturingMilliporeSigma
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
activated, big, carbon, carbon block, cartridges, ceramic candle, demineralization, double layers, drinking water at home, filter, gac, granular activated carbon, melt, pleated, polyester, polypropylene, resin, stainless steel, washable, wound sediment
We are a products, solutions and services wholesale supplier in water treatment. We provide only businesses companies such as distributors, retailers, manufacturers and assemblers.A catalog including carefully selected products, from the most prestigious brands in the Water Treatment market, operative website, personalized services, precise and efficient logistics, flexible organization, but also the basic importance that is attributed to human factors and relationships with partners, make of Sinergroup Srl a reference for many companies of the market. A continuous and consistent effort, the ability to anticipate the evolution of the market demand and orientation to the understanding and satisfaction of our customers has always characterizes us in our work.
Born with the objective view in the exclusive distribution: Continue to be "Leader of the Brand Leader ", with activities and services of value. A choice of specialization that in recent years has allowed us to develop a unique knowledge and experience in the market. The thorough water treatment market understanding and high commercial performance, make us able to offer to our customers many products and services more personalized and appropriate to the individual end user. Our mission is to become your best business Partner!
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Single-Use Tangential Flow Filtration for Closed ProcessingMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Potential Impact of Draft Annex 1 on Sterilizing FiltrationMilliporeSigma
Access the interactive recording here: https://bit.ly/2mvFxs7
Abstract:
The support for EMA GMPs related to sterile medicinal products is Annex 1. EMA, PICS and WHO have collaborated on the largest and most comprehensive revision of Annex 1 since it was first written in 1997.
There are a number of proposed changes to the sections in Annex 1 dealing with filtration, integrity testing and single-use.
This presentation will compare the current version with the proposed changes and highlight areas of specific interest to companies who either manufacture in or export to EMA countries, PICS member countries, and WHO compliant countries.
In This PPT Various Equipments Used In Pharma Industry Are Discussed. It can Be Used As Source Of Knowledge For Studnets Who Want To Gain Knowledge Other Than Books.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the quality control tests of parenteral as referred in the pharmacopoeia.
Thank you for reading. Hope it was of help to you.
UIPS,PU team
Rapid sterility testing system is an automated solution for the rapid detection, response, and resolution of microbial contamination in filterable samples throughout the manufacturing process. Accurate, rapid sterility testing is not only critical for patient safety it also makes great sense for the compounders and other pharmaceutical manufacturers.
STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATIONAVIJIT BAKSHI
PRESENTATION CONTAINS THE INFORMATION ABOUT STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATION FOLLOWED BY PHARMACEUTICAL MANUFACTURING COMPANIES.
Endotoxin Control and Clearance in BiomanufacturingMilliporeSigma
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
activated, big, carbon, carbon block, cartridges, ceramic candle, demineralization, double layers, drinking water at home, filter, gac, granular activated carbon, melt, pleated, polyester, polypropylene, resin, stainless steel, washable, wound sediment
We are a products, solutions and services wholesale supplier in water treatment. We provide only businesses companies such as distributors, retailers, manufacturers and assemblers.A catalog including carefully selected products, from the most prestigious brands in the Water Treatment market, operative website, personalized services, precise and efficient logistics, flexible organization, but also the basic importance that is attributed to human factors and relationships with partners, make of Sinergroup Srl a reference for many companies of the market. A continuous and consistent effort, the ability to anticipate the evolution of the market demand and orientation to the understanding and satisfaction of our customers has always characterizes us in our work.
Born with the objective view in the exclusive distribution: Continue to be "Leader of the Brand Leader ", with activities and services of value. A choice of specialization that in recent years has allowed us to develop a unique knowledge and experience in the market. The thorough water treatment market understanding and high commercial performance, make us able to offer to our customers many products and services more personalized and appropriate to the individual end user. Our mission is to become your best business Partner!
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Single-Use Tangential Flow Filtration for Closed ProcessingMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Webinar: Novel Perfusion Filter and Controller for N-1 ApplicationMerck Life Sciences
Participate in the interactive webinar now: http://bit.ly/SeedTrainPt2
The industry focus on process intensification is driving an increase in adoption of perfusion within the seed train. In an effort to deliver on the need for a robust solution we have developed a filter/controller duo that makes process intensification a reality!
Explore our webinar library: www.merckmillipore.com/webinars
Webinar: Novel Perfusion Filter and Controller for N-1 ApplicationMilliporeSigma
Participate in the interactive webinar now: http://bit.ly/SeedTrainPt2
The industry focus on process intensification is driving an increase in adoption of perfusion within the seed train. In an effort to deliver on the need for a robust solution we have developed a filter/controller duo that makes process intensification a reality!
Explore our webinar library: www.emdmillipore.com/webinars
The biopharmaceutical industry needs high-performance processing through the establishment of next-generation solutions to improve efficiency and effectiveness. The shift in the industry toward efficient monoclonal antibody (mAb) processing has necessitated the development of novel approaches.
In this webinar, you will learn:
• What benefits upstream process intensification brings to the manufactures addition to higher productivity
• Several scenarios with process modeling data to quantify financial benefits and value
• Perfused seed train process development data taken with our new Cellicon™ Solution and Cellvento® 4CHO-X expansion medium
Upstream process intensification can bring significant benefits to manufacturers in terms of smaller facilities, manufacturing flexibility, and reduction in footprint, with achieving significantly higher productivity. Several scenarios for Mab production become apparent with the implementation of perfusion-based operations, especially for the seed train. We will identify these scenarios with process modeling data to quantify their financial benefits and value. In addition, we will share perfused seed train process development data resulting from the use of our new Cellicon™ Solution and Cellvento® 4CHO-X expansion medium.
The biopharmaceutical industry needs high-performance processing through the establishment of next-generation solutions to improve efficiency and effectiveness. The shift in the industry toward efficient monoclonal antibody (mAb) processing has necessitated the development of novel approaches.
In this webinar, you will learn:
• What benefits upstream process intensification brings to the manufactures addition to higher productivity
• Several scenarios with process modeling data to quantify financial benefits and value
• Perfused seed train process development data taken with our new Cellicon™ Solution and Cellvento® 4CHO-X expansion medium
Upstream process intensification can bring significant benefits to manufacturers in terms of smaller facilities, manufacturing flexibility, and reduction in footprint, with achieving significantly higher productivity. Several scenarios for Mab production become apparent with the implementation of perfusion-based operations, especially for the seed train. We will identify these scenarios with process modeling data to quantify their financial benefits and value. In addition, we will share perfused seed train process development data resulting from the use of our new Cellicon™ Solution and Cellvento® 4CHO-X expansion medium.
Parvovirus Filtration Best Practices - 25 Years of Hands-On ExperienceMilliporeSigma
In this webinar, you will learn:
- how to measure filter performance and capacity,
- how to optimize filter virus removal capability,
- and avoid potential pit-falls
Detailed description:
This webinar will cover all aspects of parvovirus filtration best practices: process development/ optimization, pilot scale-up, and validation and explain the important connections between these activities. The rationale for the recommended best practices will be explained by discussing the underlying mechanisms that control filter performance.
Parvovirus Filtration Best Practices - 25 Years of Hands-On ExperienceMerck Life Sciences
In this webinar, you will learn:
- how to measure filter performance and capacity,
- how to optimize filter virus removal capability,
- and avoid potential pit-falls
Detailed description:
This webinar will cover all aspects of parvovirus filtration best practices: process development/ optimization, pilot scale-up, and validation and explain the important connections between these activities. The rationale for the recommended best practices will be explained by discussing the underlying mechanisms that control filter performance.
Find your filter. What’s best for your process? MilliporeSigma
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
Filtration Strategies for Optimal Development and Purification of a FMD Virus...MilliporeSigma
This poster presentation outlines the different filtration strategies and performances in the upstream and downstream process to develop a scalable, cost-efficient and GMP-compliant Foot and Mouth Disease (FMD) vaccine production:
• Introduction to foot and mouth disease (FMD) and background on FMD vaccines
• Review of cell culture, clarification, and concentration/diafiltration steps for the production and purification of the FMD vaccine
• Suggested further actions based on data outlined in this poster
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
Particle Size Analysis for Homogenization Process Development HORIBA Particle
Emulsions and suspensions are commonly used in pharmaceutical, chemical and consumer products. The pharmaceutical industry, in particular, uses emulsions and suspensions to increase drug efficacy by controlling their particle size and size distribution. Among various available preparation methods, high-pressure homogenization is one of the widely employed processes in the field. This webinar discusses ways to develop a robust homogenization process for making pharmaceutical emulsions by evaluating droplet size distribution.
View recorded webinars:
http://bit.ly/particlewebinars
Filtration Strategies for Optimal Development and Purification of a FMD Virus...Merck Life Sciences
This poster presentation outlines the different filtration strategies and performances in the upstream and downstream process to develop a scalable, cost-efficient and GMP-compliant Foot and Mouth Disease (FMD) vaccine production:
• Introduction to foot and mouth disease (FMD) and background on FMD vaccines
• Review of cell culture, clarification, and concentration/diafiltration steps for the production and purification of the FMD vaccine
• Suggested further actions based on data outlined in this poster
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
Implementing a Fully Single-Use, Integrated mAb Biosimilars Purification Plat...MilliporeSigma
Access the interactive recording here: https://bit.ly/2DONZaQ
Webinar summary:
1000L-scale implementation of fully connected, disposable, advanced DSP platform for next generation mAb production.
Within the biopharmaceutical industry, there is a significant shift toward higher productivity processes resulting in improved economics without compromising robustness. Therefore, integrated continuous production technologies are of greatest interest.
Next Generation Biopharmaceutical Downstream Process is a European-funded collaborative project that aims at implementing a fully integrated manufacturing platform for biosimilar mAb based on continuous chromatography, in combination with single-use disposable technologies for all unit operations of DSP on pilot/small production scale together with incorporation of advanced analytical tools.
In this webinar, you will see:
* new DSP purification template producing > 3.3 kg of mAb in 2.5 days in less than 30m²
* proof of concept for the mAb manufacturing of tomorrow
Implementing a Fully Single-Use, Integrated mAb Biosimilars Purification Plat...Merck Life Sciences
Access the interactive recording here: https://bit.ly/2DONZaQ
Webinar summary:
1000L-scale implementation of fully connected, disposable, advanced DSP platform for next generation mAb production.
Within the biopharmaceutical industry, there is a significant shift toward higher productivity processes resulting in improved economics without compromising robustness. Therefore, integrated continuous production technologies are of greatest interest.
Next Generation Biopharmaceutical Downstream Process is a European-funded collaborative project that aims at implementing a fully integrated manufacturing platform for biosimilar mAb based on continuous chromatography, in combination with single-use disposable technologies for all unit operations of DSP on pilot/small production scale together with incorporation of advanced analytical tools.
In this webinar, you will see:
* new DSP purification template producing > 3.3 kg of mAb in 2.5 days in less than 30m²
* proof of concept for the mAb manufacturing of tomorrow
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
SAP Sapphire 2024 - ASUG301 building better apps with SAP Fiori.pdfPeter Spielvogel
Building better applications for business users with SAP Fiori.
• What is SAP Fiori and why it matters to you
• How a better user experience drives measurable business benefits
• How to get started with SAP Fiori today
• How SAP Fiori elements accelerates application development
• How SAP Build Code includes SAP Fiori tools and other generative artificial intelligence capabilities
• How SAP Fiori paves the way for using AI in SAP apps
Observability Concepts EVERY Developer Should Know -- DeveloperWeek Europe.pdfPaige Cruz
Monitoring and observability aren’t traditionally found in software curriculums and many of us cobble this knowledge together from whatever vendor or ecosystem we were first introduced to and whatever is a part of your current company’s observability stack.
While the dev and ops silo continues to crumble….many organizations still relegate monitoring & observability as the purview of ops, infra and SRE teams. This is a mistake - achieving a highly observable system requires collaboration up and down the stack.
I, a former op, would like to extend an invitation to all application developers to join the observability party will share these foundational concepts to build on:
UiPath Test Automation using UiPath Test Suite series, part 3DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 3. In this session, we will cover desktop automation along with UI automation.
Topics covered:
UI automation Introduction,
UI automation Sample
Desktop automation flow
Pradeep Chinnala, Senior Consultant Automation Developer @WonderBotz and UiPath MVP
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Epistemic Interaction - tuning interfaces to provide information for AI supportAlan Dix
Paper presented at SYNERGY workshop at AVI 2024, Genoa, Italy. 3rd June 2024
https://alandix.com/academic/papers/synergy2024-epistemic/
As machine learning integrates deeper into human-computer interactions, the concept of epistemic interaction emerges, aiming to refine these interactions to enhance system adaptability. This approach encourages minor, intentional adjustments in user behaviour to enrich the data available for system learning. This paper introduces epistemic interaction within the context of human-system communication, illustrating how deliberate interaction design can improve system understanding and adaptation. Through concrete examples, we demonstrate the potential of epistemic interaction to significantly advance human-computer interaction by leveraging intuitive human communication strategies to inform system design and functionality, offering a novel pathway for enriching user-system engagements.
A tale of scale & speed: How the US Navy is enabling software delivery from l...sonjaschweigert1
Rapid and secure feature delivery is a goal across every application team and every branch of the DoD. The Navy’s DevSecOps platform, Party Barge, has achieved:
- Reduction in onboarding time from 5 weeks to 1 day
- Improved developer experience and productivity through actionable findings and reduction of false positives
- Maintenance of superior security standards and inherent policy enforcement with Authorization to Operate (ATO)
Development teams can ship efficiently and ensure applications are cyber ready for Navy Authorizing Officials (AOs). In this webinar, Sigma Defense and Anchore will give attendees a look behind the scenes and demo secure pipeline automation and security artifacts that speed up application ATO and time to production.
We will cover:
- How to remove silos in DevSecOps
- How to build efficient development pipeline roles and component templates
- How to deliver security artifacts that matter for ATO’s (SBOMs, vulnerability reports, and policy evidence)
- How to streamline operations with automated policy checks on container images
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
1. Introducing the new low volume Microfluidizer the LV1 small sample volume (1-20ml), high pressure (30KPSI) and near total sample recovery. Multiple systems scalable from 1 ml to gallons per minute. Perfect for R&D, discovery, discovery exploratory, small clinical studies, pilot scale right through to production scale systems
2. ` The new low voulme 1–20ml Microfluidizer the LV1 To learn more about the LV1 or the differences between the Microfluidizers, homogenizers and the French Press please go to www.microfluidicscorp.com and go to our Webinars Tab or continue with this presentation Bill Travers Manufacturer’s Representative Mobile: 410-746-0488 [email_address] Perfect for Nanoemulsions | Nanodispersions | Liposomes | Cell Disruption | Continuous Crystallization (Replace your obsolete French Press)
3.
4. Discover the Difference: Microfluidizer ® Processors vs. Homogenizers, Sonicators and the French Press
5.
6.
7. Heart of the Technology Fixed-Geometry Interaction Chamber - Microfluidics exclusive - Generates incredibly high shear and impact forces - Precisely engineered microchannels - Repeatable and scalable results - Diamond or ceramic construction More than Machines - Proof of Concept - Process Development - Preventive Maintenance - Safeguard Spares™ - Scaleup consulting - MRT Development
8. Applications and Benefits Pharmaceutical Biotechnology Chemical Energy More efficient catalysts and scaleable processes for fuel cells, batteries, photovoltaics and biofuels Cosmetics Brighter colors and controlled actives delivery for premium and natural lipsticks, hair sprays, clays, etc. Food/Nutraceuticals New ingredient flavors, time-release vitamins and encapsulated odors of nutrients such as Omega-3 Select Applications Proven Benefits Vaccines & adjuvants Improved bioavailability Oncology (injectables) Controlled drug delivery Asthma (inhalables) Sterile filtration Antibiotics Extended shelf life Steroids Continuous processing Select Applications Proven Benefits E. coli High rupture rates Yeast Maximized protein yield Algae Temperature control Mammalian Lower pressures/fewer passes Plant, insect, etc. No contamination Select Applications Proven Benefits Carbon nanotubes Uniform dispersions Inkjet inks Less energy required Coatings & sealants Consistent product quality Fine chemicals Easy to use and clean Polymers & waxes Agrochemicals
9. Our Customers Pharma/Biotech Chemical Food and Nutraceuticals Higher Education Over 150 Machines Sold in 2010 3M | Alcon Labs | Allergan | Aveda | BASF | Baxter | Center for Disease Control | Dana Farber General Mills | Max Planck Institute | MedImmune | Nektar Therapeutics | National Institute of Health PepsiCo. | RiteDose | SAIC | Scripps Research Institute | U.S. Army | U.S. Cosmetics | Yantai Spandex Plus dozens of universities as part of our global Academic Research Collaboration (ARC) program Cosmetic
18. Before After 15 passes 0 p 1p 2p 3p 4p 5p 7p 10p 15p Process pressure : 18,000 psi (1241 bar) Chamber: F20Y (75 microns) Final product is translucent O/W - Drug Nanoemulsion (Cancer Drug)
19. Median = 0.075 m Median = 14.53 m Before After Emulsion: Oxygen Carrier (Perfluorocarbon) in a Cosmetic Application
20. Liposome Results Particle Size Consistent with emulsions, average particle sizes with Microfluidizer are approximately half the size Uniformity Variability advantages are even more pronounced here – the homogenizer sample contains multiple peaks Did You Know? Microfluidics was originally founded as a liposome producing company Microfluidizer Processor Leading Homogenizer Pass 1 113 nm 268 nm Pass 2 95 nm 228 nm Pass 3 72 nm 183 nm
25. Customer Success Story: Corixa (now GSK) Vaccine Adjuvant Nanoemulsion Based on these data, Corixa switched from their leading homogenization equipment to a Microfluidics-powered production environment Critical Quality Criteria Leading Homogenizer Microfluidizer Average Particle Size 185 nm after 15 passes 141 nm after 3 passes Goal: <150 nm Polydispersity 43% above 200 nm 0.5% above 200 nm Goal: <10% above 200 nm Active Concentration 15% loss of actives 1% loss of actives Goal: <2% loss of actives 640 cm 2 17 cm 2 Microfluidics reduced filter area required by over 97%
34. Comparison to Other Mechanical Methods * Now available with the LV1 Microfluidizer processor Microfluidizer Homogenizer Bead Mill Continuous Yes Yes No Scalable Yes Limited Yes Optimal Temp Control Yes Yes No Contamination Free Yes Uncertain No Minimum Volume 1ml* 10 ml 1 ml Constant Shear Rate Yes No No Shear Rate Potential Highest High Medium
35. BEFORE AFTER Process pressure : 18,000 psi (1241 bar) Chamber: H10Z (100 microns) Shear rate: 5.58 X 10 6 s -1 E. Coli Microfluidics users typically rupture >99% of E. coli cells in a single pass
36. Yeast Lysis ( S. Pombe ) Unprocessed 1 pass ~60% lysis 5 passes ~95% lysis 10 passes ~99% lysis Process conditions : 30,000 psi (2070 bar) Chamber: G10Z (87 microns) Shear rate per pass: 6.94 X 10 6 s -1 Microfluidizers are tough on cells (even yeast) and gentle on proteins
37.
38.
39.
40. Algae Cell Disruption Example #1 Process conditions : 1 passes 10,000 psi (690 bar) Chamber: H10Z (100 microns) Shear rate: 4.14 X 10 6 s -1
41. BEFORE AFTER Process conditions : 3 passes 20,000 psi (1380 bar) Chamber: G10Z (87 microns) Shear rate: 6.09 X 10 6 s -1 Algae Cell Disruption Example #2
42.
43.
Editor's Notes
Example of a cancer drug emulsion. The oil droplets are shown at the unprocessed material (BEFORE) but cannot be seen at the unprocessed material (AFTER) because they are very small. The plot shows the particle size distribution of the unprocessed material – median particle size of processed material 45 nanometers.
Germaben – antimicrobial, Fomblin – foam stabilizer, Poloxamer 188 (surfactant) 2 passes, M-110EH, F20Y, 20kpsi Perfluorocarbon increases the oxygen content of skin, which in turn aids in rapidly healing damaged tissue and minimizing scarring. It further aids in skin hydration and &quot;plumps&quot; the skin to produce smoother skin and reduce the appearance of fine lines. The goal of this test was to encapsulate the perfluorocarbon in an oil and water emulsion for reduce the median particle size to <100 nm for transdermal delivery through the skin to the cellular level. This was also done with 30%wt. oil for the formulation. We have had success with up to 60% oil for oil in water emulsions
4 passes, F20Y, M-110Y, 22 kpsi Vitamin C is an essential anti-oxidant and nutrient for our bodies. The goal of this customer was to use a liposome to deliver vitamin C transdermally through the skin as a component of any number of creams or moisturizers they were marketing. Additionally the liposome would act as a protective encapsulant to prevent oxidation or degradation of the vitamin C over time while on the shelf. We needed to prove that we could encapsulate the vitamin C inside of the liposome and make the median particle size less than 200 nm for transdermal delivery.