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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.
Click here to view a PDF of this article.
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.
May 01, 2018
A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical processes and systems.
Process understanding and careful assessment of risks are essential in developing viral clearance programs.