Search results for " design"
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Comparable rates of growth are also seen with outsourcing of design of experiments (from 21.4% to 43.2%) and quality-by-design (QbD) services (from 19.3% to 42%). These activities are still at the bot…
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Bioprocessing Advances in Vaccine Manufacture
With advancing SUS technology, better plastics and new designs are being developed using SUS (vs. stainless steel) for their application in precommercial R&D, clinical-trial-material supply, and comme…
Article
Trends in Downstream Bioprocessing
• Current downstream/purification areas were not designed to handle this increase in production.
• Buffer capacity, column size, UF membrane area are all problems.
• Primary clarification is a…
Article
A Platform Approach for the Purification of Domain Antibodies (Dabs)
All purification steps were optimized by Design of Experiments (DoE), thereby supporting a Quality by Design (QbD) approach.
Using Capto L, Capto MMC ImpRes, and Capto adhere ImpRes media in …
Article
Prescribing Caution for Biosimilars
Briefly stated, these principals are:
•Substitution should occur only when FDA has designated a biologic product as interchangeable
•The prescribing physician should be able to designate a pre…
Article
Considerations in depth filter scale-up
Recent work has highlighted the importance of how capsule design can affect scalability of depth filters. In this work, we present scalability data across a full range of process development-scale, pi…
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Reviewing the Importance of Biosimilarity and Interchangeability
“Clinical studies for interchangeability are specifically designed to assess the impact of switching between the biosimilar and the reference product on safety and efficacy outcomes. These studies may…
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Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
…opment of the range
• A close-up of the product range showcasing its innovative, user-friendly design
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Article
Filtration methods to overcome new challenges in viral safety
41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filtration, demonstrating how both specific methods and advanced filter design can overcome these challenges.
READ FUL…
Article
Top Tips for Successful Development of Antibody Chromatography Processes
So that will speed up the experiments that you're running, but also utilize the design of experiment, where you want to get the most out of each individual experiment. Each experiment will not give yo…