Current Issue
Finding Opportunities in Brazil
Changes in the country’s political landscape may affect the pharmaceutical industry market in the future.
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Rapid Early Process Development Enabled by Commercial Chemically Defined Media and Microbioreactors
The use of commercially available media to achieve high titer in early process development is discussed.
Outsourcing
The Global Biomanufacturing Outsourcing Market
The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.
FDA Issues Draft Guidance for Repackaging Biological Products
The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.
FDA Issues Guidance on Drug Compounding
The agency releases five draft guidance documents related to drug compounding and repackaging.
Standards/Regulations
FDA Postpones Hearing for Remicade Biosimilar
FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.
Manufacturers Weigh Strategies to Prevent Drug Shortages
Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.
Sagent Pharmaceuticals Recalls Atracurium Besylate Injection
The company voluntarily recalls product due to FDA observations of potential sterility problems.
Webcasts
Sponsored Links
