Search results for " guidance"
Article
Reimagining Affordable Biosimilars
European Medicine Agency (EMA) biosimilar guidance provide recommendations for such predictive tools as supportive information for biosimilarity (17).
Thus, establishing biosimilarity requires an…
Article
EMA Confirms Standards for COVID-19 Treatment Evaluations
It provides guidance on the development of COVID-19 treatments; it reviews and requests data from developers; and it works as an advisor to the Scientific Advice Working Party (SAWP)/Committee for Med…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Automation software can provide guidance in ensuring that a single-use flow-path is properly connected, thereby saving time performing manual validation, Shave adds. The software can also generate aut…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
…mpling of powder raw materials requires rapid material usage post-sampling to comply with regulatory guidance.
The physical properties of powders require extensive cleaning of clas…
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Make the Switch from ELISA to Biacore™ SPR-Based Assays Today
General guidance on how to convert an existing ELISA assay to a Biacore surface plasmon resonance (SPR) assay and how, by doing so, you can get results in less than half the time compared with ELISA. …
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Supply Chain Challenges for Single-Use Systems
Managing change is challenging in a rapidly growing market with continuous evolving guidance that requires a smart risk-based approach. One size does not fit all. We have extensive knowledge of our cu…
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A Look into the Future of Biopharmaceutical Quality
…uidelines would not ensure the quality of biologics in the future, but it’s likely that regulatory guidance documents will continue to be revised and updated over time to adopt industry best practice…
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Biopharma Seeks Balance
The methods FDA uses to regulate gene and cell therapies will evolve, Marks said, and Gottlieb noted that FDA will produce guidance documents for gene therapy in 2018.
A fine balance
For patie…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
Article
Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
By Cynthia A. Challener
Tashatuvango/Shu…