Search results for " safety"
Article
Tools and Solutions for Separation of Charged mAb Variants
To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be demonstrated. Biomolecules, however, exhibit high structural complexity …
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
We want to focus on the ones that relate to the functional characteristics of exosomes and how they might behave from a safety and efficacy standpoint in the clinic. For exosomes, what you look at is …
Article
Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
These modifications can profoundly affect protein quality relevant to clinical efficacy, safety, and half-life of biologics (1). Mammalian cells meet these criteria quite efficiently by virtue of thei…
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Downstream Processing for Cell-Based Therapies
A biological safety cabinet usually is needed for the subsequent resuspension step, which involves discarding spent medium and resuspending in a suitable buffer. This process may be repeated multiple …
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Accelerated flavivirus vaccine production with modern tools and solutions
Single-use production bioreactors and chromatography purification columnsmitigate cross-contamination risk and support increased operator safety, while reducing time to market by eliminating costly an…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
According to Jason Schuman, a senior product specialist at Cytiva, Biacore is used to screen hybridoma lysates for selection of lead candidates, to measure binding properties, and to evaluate safety, …
Poster
Collaborating to address the bioburden challenge
Bacteria and their byproducts can negatively affect the safety and potency of a biopharmaceutical drug. At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batche…
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Managing Risk in Raw Material Sourcing
…r bulk pharmaceutical excipients) guidelines to continuously improve our systems and ensure quality, safety, and functionality of pharmaceutical excipients,” says Ohri.
Guiding supplier selection…
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Advancing Single-Use Technology Through Collaboration
…(ASTM) International, BPOG, the Bio-Process Systems Alliance (BPSA), the Extractables and Leachables Safety Information Exchange (ELSIE), the International Society for Pharmaceutical Engineering (ISP…