Search results for " safety" in Articles / App Notes
Article
Platform Technologies Improve Protein Expression
Manufacturers are seeking mechanisms for increasing efficiencies and reducing costs without compromising the safety and efficacy of their drug products. In addition to exploring novel production metho…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
From the outset, FDA reviewers said that efficacy was not an issue due to overwhelming patient response to treatment, and that safety would involve long-term post-market assessment. But the experts s…
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Bioburden Control in the Biopharmaceutical Industry
The Center for Food Safety and Applied Nutrition (CFSAN)—under FDA—provided a comprehensive collection of pathogenic microbes in Bad Bug Book including: Trychophyton species, Serratia marcescens, Neis…
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Biosimilars to Drive Modern Manufacturing Approaches
…of implementing high-tech strategies and sound oversight policies to overcome concerns about product safety and effectiveness. FDA officials are emphasizing how advanced analytical methods can docume…
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Biosimilars: Making the Switch Comes with Challenges
There continues to be widespread scepticism in the region about the quality and safety of biosimilars, and sometimes their efficacy, among physicians and patients. This issue is often because of a lac…
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Lessons Learned Accelerate Vaccine Development
The absence of predictive animal models complicates the issue; while safety can be established in animals, immunogenicity is harder to correlate, and as a result the effectiveness of a vaccine is ofte…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
…ould be possible to predict that any differences in quality attributes have no adverse impact on the safety or efficacy of the drug product (16). Manufacturing changes may be frequent and approval ti…
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The Metrics of Quality Culture
The intent of FDA to establish quality metrics first emerged in 2012 when Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) enhancing FDA’s capability to proactively …
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A Bright Future for the Plasma Fractionation Industry
Day two of the PPB meeting started with the Pathogen safety session, chaired by Hannelore Willkommen. Three opening presentations dealt with the Hepatitis E Virus (HEV) issue from a risk, regulatory, …
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Quality by Design and Extractable and Leachable Testing
Feb 01, 2015
By Anthony Grilli
BioPharm International
Biopharmaceutical packaging performs several vital functions in assuring the drug product safety. First and foremost, packaging must b…