Search results for " patients" in Articles / App Notes
Article
Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
It has been and is currently being administered to COVID-19 patients at New York City area hospitals as part of an emergency investigational new drug (EIND), granted by FDA as part of Phase I, Phase I…
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Mapping a Route for Cell and Gene Therapy Process Development
“To produce products for large numbers of patients would require running of hundreds to thousands of parallel processes in a cleanroom environment, which is not feasible. It will be necessary to devel…
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Leveraging Computational Models of Glycosylation for Biopharma QA
…ct the intracellular process of glycosylation (1,3) and yield product that cannot be administered to patients. Due to its bioprocess-associated variability and impact on safety, pharmacokinetics, and…
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Drug Quality Key to Innovation and Access
…rmaceutical manufacturers will face a host of issues in bringing safe and effective new therapies to patients. The demand for affordable personalized, or precision, medicines to treat lethal diseases…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
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A Bright Future for the Plasma Fractionation Industry
Some of the examples given by Perreault were in the area of recombinant plasma proteins, disruptive technologies, and especially improved diagnosis of patients and better access to therapeutics. Perre…
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Modular Manufacturing Platforms for Biologics
He says G-CON has been approached to design a mobile containment system to be able to segregate patients. “The transmissible disease containment systems range from patient transfer to installed patien…
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FDA Approves First Biosimilar
The medication is now approved in the US for all five of the same indications as Amgen’s Neupogen (filgrastim), including for patients receiving myelosuppressive chemotherapy, with acute myeloid leuke…
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Drugs, At What Cost?
The underlying question for any drug in development is: What price can (or will) patients pay for the needed therapy? Patient sticker shock, government austerity programs, blockbuster drugs falling of…
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Supplier-Change Management for Drug-Product Manufacturers
…are safe, effective, meet established regulatory expectations and licenses, and are available to the patients who rely on them. Pharmaceutical change management processes extend to the materials and …