Manufacturing Best Practices

May 01, 2017
BioPharm International
Can bioprocessing runs be consistently replicated in an inherently variable production environment?
Mar 02, 2017
The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.
Feb 01, 2017
BioPharm International
To prevent failure during lengthy use, tube life should be monitored and a preventive maintenance program enacted.
Jul 01, 2016
BioPharm International
A streamlined approach may enhance process efficiency and product quality.
Jun 09, 2016
The inactivated vaccine, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option.
Apr 01, 2016
BioPharm International
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.
Sep 16, 2015
Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.
Sep 10, 2015
By BioPharm International Editors
FDA announced the recall, citing deficiencies in Medistat’s aseptic processing areas and in its environmental monitoring procedures.
Aug 13, 2015
Juno says its manufacturing and ex-vivo cellular engineering capabilities will be key to the company’s success.
Jul 28, 2015
A new study published in JAMA Internal Medicine found that manufacturers do not report a portion of adverse events to FDA within the federally mandated time frame of 15 days.
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