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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
June 01, 2021
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
May 26, 2021
ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.
May 16, 2021
Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.
The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.
May 01, 2021
A best practices approach to pharma’s most challenging-to-inspect container.
System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.
April 21, 2021
Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.
April 20, 2021
FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.
April 15, 2021
This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.