Search results for " review" in Articles / App Notes
Article
Process Development: What May Lie Ahead in 2018?
Readers were very interested to learn how to prevent bioburden incidents in this article written by a former FDA BLA reviewer and inspector. Also hot was a second piece on protecting against microbiol…
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What's in Your SOP?
This activity might be acceptable on the condition that the purchased SOP is reviewed and the appropriate changes be made to reflect the actual operations of the company who purchased the SOP. Failure…
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Bioburden Entry Points in Downstream Processing
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips in this blog.
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Transformative Medicines Challenge FDA and Manufacturers
FDA published a draft guidance in February 2016 on human factors studies for combination products (2) and is reviewing comments to finalize the policy.
As FDA and industry continue to scope ou…
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Prepare for an FDA Bioburden Inspection
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips.
Read blog here
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Contract Manufacturing Through the Years
In light of Pharmaceutical Technology’s 40th anniversary, it is appropriate to review the CDMO industry’s evolution and outlook.
Early days
Phase one of the CDMO industry includes the y…
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N-Glycan Analysis of Biotherapeutic Proteins
In this article, the biological effects of N-glycosylation on protein biologics are reviewed—together with the range of analytical techniques that are used to elucidate the N-glycosylation characteris…
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Managing Residual Impurities During Downstream Processing
…hnology that provide enhanced means of monitoring--have, however, been key drivers for the continued review and optimization of guidelines for the manufacture of biologic drugs, according to Ashleigh…
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Automating Bioprocesses
Companies have been moving towards CPV rather than annual product reviews. Requirements are emerging, particularly for biopharmaceuticals, to provide CPV across all manufacturing locations for a produ…
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Ensuring Sterility in Small-Scale Production
Determining the appropriate monitoring locations should be determined through a comprehensive risk evaluation that should periodically be reviewed and updated to reflect the most current operating con…