Search results for " safety" in Articles / App Notes
Article
Setting Up Bioprocessing Systems for Digital Transformation
… that nobody changed the alarm limits on temperature levels or other variables that might impact the safety and efficacy of the final product,” Lenich asserts.
Fitting in AI
The use of artifi…
Article
Technology Innovations Improve Process Chromatography Performance
“We are also seeing that, as regulatory limits impose restrictions for ensuring customer safety, like toxicology and cleaning validation for GMP [good manufacturing practices] environments, off-the-sh…
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Good Manufacturing Practices: Challenges with Compliance
These address much of the obvious concerns such as potency, safety, and containment. There is less guidance, however, on how to formulate and develop a more complex biological drug product as you reac…
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Addressing the Complex Nature of Downstream Processing with QbD
QbD in viral clearance
Viral clearance is connected to patient safety, according to Malmquist. During downstream processing, virus inactivation, virus filtration, and chromatography steps are perf…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it challenging to apply quality-by-design (QbD) methods and process analytic…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
This update of a 2008 advisory describes how manufacturers should provide sufficient CMC information to assure the safety, identity, quality, purity, and strength/potency of investigational gene thera…
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A Look into the Future of Biopharmaceutical Quality
These complex therapies have evolved, and with this evolution comes new challenges in ensuring the quality of these products and the safety of the patients that use them. Quality regulations, and indu…
Article
Understanding Validation and Technical Transfer, Part 3
Processing, holding, and expiration periods should be evaluated and established to ensure product safety (i.e., freedom from objectionable levels of endotoxin and microbial contamination) and efficacy…
Article
CoAs Help Secure the Supply Chain
The safety of the pharmaceutical supply chain is of concern to regulators, manufacturers, practitioners, and patients. The process of assuring the suitability of suppliers of pharmaceutical ingredient…
Article
Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
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