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September 26, 2017
UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).
August 01, 2017
The International Society for Pharmaceutical Engineering (ISPE) introduced its Biopharmaceutical Manufacturing Conference, happening December 4–6, 2017 in San Francisco, California.
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
July 01, 2017
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
May 01, 2017
Can bioprocessing runs be consistently replicated in an inherently variable production environment?
April 25, 2017
Lonza revealed it received a warning letter from FDA for its cell therapy manufacturing plant.
October 19, 2016
The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.
July 01, 2016
The author provides a review of the concepts of design and qualification that apply to single-use systems.
April 25, 2016
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
December 07, 2015
While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.