Search results for "regulatory" in Articles / App Notes
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Over the past several decades, numerous recombinant proteins have been approved as therapeutic drugs by regulatory authorities, and many more are currently undergoing clinical development (1). Chinese…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
These developments have been timely, as regulatory authorities’ requirement for better understanding of product and process has encouraged a process-space approach to bioprocess development.
Chara…
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Implications of Cell Culture Conditions on Protein Glycosylation
Regulatory guidelines require extensive analytical testing side by side with the innovator drug, including full glycosylation profiles (3). Similarity to the innovator drug is paramount; this must beg…
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Aseptic Processing: Keeping it Safe
Although states currently oversee the activities of compounding pharmacies, FDA released new draft guidance documents in February 2015 seeking to exert more regulatory control over drugs produced by s…
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Use of Multivariate Data Analysis in Bioprocessing
In fact, the underlying essence of biosimilar development is that if the manufacturer is able to demonstrate high similarity between innovator and their biosimilar version, the regulatory authorities …
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Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…
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Ensuring the Quality of Biologicals
This new approach is aligned with the development approach for biosimilars and involves communication channels between the main regulatory players in Europe: EMA, national authorities, and the Europea…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Regulatory agencies are increasingly asking drug manufacturers to characterize particulate matter in biologics.
Unfortunately, there is little general agreement about how to handle the problem of …
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Tackling Analytical Method Development for ADCs
In such a rapidly evolving area, the regulatory requirements are clearly evolving as more knowledge makes it into health authority submissions and into the peer-reviewed literature,” he says.
On t…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
…earch engineer; Shujian Yi, PhD, is senior polymer scientist; and Jeffrey Carter, PhD, is strategic regulatory services leader, all at Cytiva. Pokon Ganguli is R&D manager at Renolit Nederland B.V., …