Search results for " safety"
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
…
Article
FDA Framework Spurs Advanced Therapies
…eakneck speed of advancement in the products we’re being asked to evaluate, while ensuring patient safety.”
To that end, the agency introduced in mid-November 2017 a new comprehensive framewor…
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Process Development: What May Lie Ahead in 2018?
Safety and Regulatory Concerns
As scientific breakthroughs continue to advance the biopharmaceutical industry, safety issues (new and old) must also remain a top-of-mind concern for the biopharmac…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Manufacturers must not only speed product delivery but ensure quality, safety, and efficacy. Success demands consistent discipline and rigor from supply chain and manufacturing operations, as well as …
Article
Reducing Cross-Contamination Risks in Process Chromatography
When single-use is not viable
After issues of safety and process economics are considered, technical feasibility determines whether single-use chromatography will be used in a given manufactur…
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N-Glycan Analysis of Biotherapeutic Proteins
N-glycans of antibody and antibody-derived biotherapeutics
The influence of N-glycans on the efficacy, stability, half-life, and safety of antibody and antibody-derived biotherapeutics are well-re…
Article
From Darwin to Recombinant Fc Multimers
no biosimilars
• Continued innovation, investment and progress
To ensure future vitality of the industry, Perkins talked about the importance of securing plasma supply, donor and patient safet…
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Being Thorough When Transferring Technology
Removal of residual cytotoxin is critical for preservation of drug substance safety and is a unique process step relative to the typical biological manufacturing process.
Detection of residual cyt…
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Witnessing Major Growth in Next-Generation Antibodies
For next-generation products, delivery methods that give the best therapeutic effects, safety profiles, and convenience for the patient, the latter becoming increasingly important, should be the goal,…
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Drug Quality Key to Innovation and Access
A similar situation recently emerged related to approving a new antibiotic that promises to address critical medical needs due to spreading antibiotic resistance, but has presented serious safety issu…