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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.
April 01, 2018
This is the first of a series of three articles about validation and technical transfer in the bio- pharmaceutical industry.
March 15, 2018
Process validation is an extension of biologics development processes.
November 01, 2017
This article demonstrates that a modified SDS–PAGE can be easily used as a tool for quantifying the degree of protein degradation.
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.