Search results for " drug"
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Preparing for the Future: Visions and Insights for Biomanufacturing
Yet, new market dynamics, such as growing competition from biosimilars and niche drugs targeting smaller patient populations, are reshaping how drugs are produced and sold.
To keep up with this c…
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Putting Viral Clearance Capabilities to the Test
When applying for regulatory approval, a drug license holder must demonstrate that its proposed manufacturing process can remove or inactivate potential viral contaminants.
Viral clearance studies…
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CoAs Help Secure the Supply Chain
Some latitude is given for drug product containers and closures. Some of the tests that need to be performed to verify the results on the CoA for containers and closures may not be practical for the p…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA, FDA Briefing Document, Oncologic Drugs Advisory Committee Meeting, BLA 125646.
6. Novartis, “Oncologic Drugs Advisory Committee Briefing Document, Tisagenlecleucel (CTL019),” July 12, 2017…
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Bioburden Control in the Biopharmaceutical Industry
Conclusion
The biologics sector is continually expanding because these drugs demonstrate better therapeutic value in treating an increasing number of chronic diseases (18). Biologics manufacturing…
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From Darwin to Recombinant Fc Multimers
Carlos Bosques from Momenta Pharmaceuticals had a presentation titled IVIg-Inspired Drugs for Improved Therapy in Autoimmune Diseases in the Application session. IVIg has been a treatment optio…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Similar cell-culture media may be used simultaneously in one or few biological processes at a drug product manufacturing facility. As per Code of Federal Regulations (CFR) 211. 84, each media needs to…
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Modular Manufacturing Platforms for Biologics
While the industry will continue to look for ways to reduce capital investment when bringing a drug to market, Emel says that “the holy grail may very well be continuous processing, which could make m…
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Labeling of Biosimilars
This guideline states that, as with generic drugs, the biosimilar’s summary of product characteristics (SmPC) has to be derived from those of the reference product.
“The general principle is that t…
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Fermentation for the Future
Newer drug substances, such as single-domain antibodies, peptibodies, or antibody fragments that contain the effective domains, have recently been produced using microbes.
Microbial expression is …