A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.
The all-synthetic clarifying product line contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.
Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.
As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.
Is there enough talent to go around?
Commissioner Margaret Hamburg discusses globalization challenges and the need for investment in regulatory science during her last weeks at the agency.
The agency outlines recommendations for the development and submission of near infrared analytical procedures.
Drug makers back alternative to FDA labeling update rule.