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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
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.
April 09, 2021
Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.
April 01, 2021
Dynamic light scattering presents a good analytical technique for testing protein stability.
March 16, 2021
Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
March 15, 2021
A growing pipeline of gene therapy candidates aimed at treating neurodegenerative diseases has prompted new guidance.
March 01, 2021
Auditing distribution suppliers provides understanding and documentation of the services performed.
February 04, 2021
The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.