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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
December 01, 2020
The industry is moving beyond cleaning’s “low tech” image to embrace science-based limits and statistical approaches to control.
October 16, 2020
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
July 07, 2020
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.
June 30, 2020
The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.
April 01, 2020
Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.
January 01, 2020
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
April 01, 2019
Getting the science right helps biopharma startups overcome development and commercialization challenges.
March 01, 2019
A properly designed validation program will detect variation and ensure control based on process risk.
September 01, 2018
This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
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July 26, 2018
Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.