Manufacturing, Aseptic Processing

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.
Feb 27, 2017
By BioPharm International Editors
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
Feb 16, 2017
By BioPharm International Editors
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
Feb 15, 2017
By BioPharm International Editors
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
Feb 15, 2017
By BioPharm International Editors
The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
Feb 08, 2017
By BioPharm International Editors
Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.
Feb 01, 2017
BioPharm International
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.
Jan 09, 2017
By BioPharm International Editors
The company was cited by FDA for violations of sterile processing GMPs.
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