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May 03, 2024
A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.
May 02, 2024
Key areas to invest include manufacturing process improvements, quality management, and AI.
May 01, 2024
The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.
April 26, 2024
Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy, helps adults with hemophilia B produce factor IX themselves instead of receiving regular intravenous infusions.
April 25, 2024
The approval, given across three indications, follows a previous approval for second-line use in esophageal squamous cell carcinoma.
April 24, 2024
GSK’s supplemental Biologics License Application for its PD-1-blocking antibody therapy has been accepted for review by FDA.
At INTERPHEX 2024, BioPharm International spoke with Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, about how to effectively conduct sterile powder transfer during the fill/finish step in parenteral drug product manufacturing.
Current trends, such as single-use technologies, presen advantages and new challenges for pumping systems, according to Andreas Frerix, product management director for Quattroflow at PSG Biotech.
April 23, 2024
As the industry adjusts to new regulations, including Annex 1, bio/pharma manufacturers must rethink facility designs to remain in compliance.
At INTERPHEX 2024, Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, discussed how the advancement of sensor technologies are being shaped by current industry trends.