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Process validation is an extension of biologics development processes.
When it comes to outsourcing process validation of biologics, Abel Hastings, director of process sciences at FUJIFILM Diosynth Biotechnologies, says that the relationship between a contract development and manufacturing organization (CDMO) and sponsor is key in ensuring successful process validation. “Customers that are open about their strategy, their data (good and bad), and their own strengths and weaknesses are most successful.”
BioPharm International spoke with Hastings about the specific challenges that arise in the process validation of biologics.
Read this article in BioPharm International's Outsourcing Resources 2018 eBook.
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eBook: Outsourcing Resources 2018
When referring to this article, please cite it as S. Haigney, "Process Validation in Biologics Development," BioPharm International Outsourcing Resources eBook (March 2018).