Manufacturing, Aseptic Processing

Jan 01, 2017
BioPharm International
Excipient selection strongly influences lyophilization performance for biologic drugs.
Dec 01, 2016
BioPharm International
John Ward, vice-president of Engineering at Patheon, discusses the potential for cross contamination in the manufacture of biopharmaceuticals.
Oct 02, 2016
BioPharm International
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
Oct 01, 2016
BioPharm International
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
Sep 23, 2016
By BioPharm International Editors
Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.
Sep 14, 2016
By BioPharm International Editors
FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
Sep 01, 2016
BioPharm International
Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?
Aug 01, 2016
BioPharm International
Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.
Jul 19, 2016
By BioPharm International Editors
FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
Jul 01, 2016
BioPharm International
Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
native1_300x100
lorem ipsum