Manufacturing, Aseptic Processing

Sep 01, 2017
BioPharm International
The control of biologics microbiological impurities, contaminants, and mimetics is evolving.
Sep 01, 2017
BioPharm International
Choosing a suitable material for fill/finish containers begins during the product development stage.
Aug 25, 2017
By BioPharm International Editors
Ajinomoto Althea’s Optima VFVM 7000 aseptic fill/finish line supports a range of drug substance APIs.
Jul 25, 2017
By BioPharm International Editors
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
Jun 26, 2017
By BioPharm International Editors
Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.
Jun 19, 2017
By BioPharm International Editors
The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.
Jun 14, 2017
By BioPharm International Editors
FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
May 09, 2017
By BioPharm International Editors
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
May 05, 2017
By BioPharm International Editors
Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.
May 01, 2017
BioPharm International
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
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