Search results for " report"
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Presence of α-1,3 galactose residues has been reported to cause fatal anaphylaxis in patients treated with Cetuximab (Erbitux, Bristol-Myers Squibb/Merck) (9,11). These cases occurred in patients who …
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Ensuring Viral Safety of Viral Vaccines and Vectors
Extraneous vesiviruses, however, have recently appeared in bioreactors (2–5), and porcine circovirus type 1 (PCV-1) contamination of oral rotavirus vaccines was first reported by a metagenomics analys…
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Biopharma Seeks Balance
FDA reports that it has considered emerging technologies for biological molecules including controlled ice nucleation for lyophilization processes, predictive modeling for process monitoring and close…
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Miniaturization to Become Even More Successful
An extended report from the HTPD conference has now been completed with 15 different presentations highlighted.
Read more about the report and download it here.
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Utilization of Mechanistic Modeling to Improve Process Development
An extended report from the conference has now been completed with 15 different presentations highlighted.
Read more about the report and download it here.
Article
Understanding Validation and Technical Transfer, Part I
It is not a stack of protocols and reports designed to satisfy regulatory expectations. It is not following by rote a series of “qualifications” such as design (DQ), installation (IQ), operational (OQ…
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Modern Manufacturing Key to More Effective Vaccines
Powaleny, “New Report and Event Examine the New Era of Vaccines,” The Catalyst, Nov. 9, 2017.
2. Sanofi, “Sanofi Updates Information on Dengue Vaccine,” Press Release, Nov. 29, 2017.
3.…
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Being Thorough When Transferring Technology
For example, when single-use bioreactors were a nascent technology to the industry, there were reports that some bags melted on the larger bioreactors. Someone didn’t anticipate the heating and coolin…
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Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…
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Advancing Single-Use Technology Through Collaboration
Three quarters of the end users surveyed as part of the 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production agreed or strongly agreed that concerns with leachables…