Search results for " PAT"
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2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
In a recent survey of current trends and practices in biopharmaceutical manufacturing…
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Essentials in Quality Risk Management
…, definition, analytical method, and associated process changes are understood and managed to ensure patient safety and drug efficacy. An effective QRM process can further ensure the high quality of …
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Advancing QbD in the EU
The agency has seen its PAT team as a key element in the implementation of QbD by encouraging process understanding. This knowledge becomes a basis for achieving quality by ensuring pre-defined qualit…
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Report from the 12th Plasma Product Biotechnology Forum
Despite the unusual raw material, there is a well-established and understood regulatory pathway through FDA-CBER. SAb Therapeutics has several projects in the pipeline, spanning from Phase 1 to Phase …
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Mechanistic modeling is considered a part of smart process development, which is a collection of approaches to get better process outcomes and speed up process development.
This week, Bioproce…
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Achieving Process Balance with Perfusion Bioreactors
Fluid paths that decrease shear are key as well, according to Levison. “It is not just the design of the biocontainers, but also the impellers and aerator that can have a great impact on how the cells…
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Hybrid Bioprocessing: A Q&A with Andrew Sinclair
It has the potential for a step change though in my view, it will require innovative thinking around, automation, PAT, and online release to realize its full potential.
It is often stated that con…
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Being Thorough When Transferring Technology
These data should be tied to patient outcomes.
Lonza: The unique characteristics of an antibody-drug conjugate--a small-molecule cytotoxic moiety attached by chemical linker to an antibody--demand…
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Automating Bioprocesses
Automation of stainless-steel systems and single-use systems differs in complexity.
By Jennifer Markarian
Both upstream and downstream biopharmaceutical processes have conventionally used st…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ntitious viral agent contamination and to ensure uninterrupted supply of safe biological products to patients in need.
Product safety and quality by design (QbD)
Traditionally, product safety…