Search results for "outsourcing"
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015
By Agnes Shanley
BioPharm International eBooks
Volume 28, Issue 13
Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…
Article
Technologies and Practices Must Evolve to Meet Demand
Jan 01, 2015 By Rita Peters
Through Dec. 3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule …
Article
Securing the Single-Use Supply Chain
…ucena, product strategy manager-ReadyToProcess with Cytiva, which is that their use is analogous to outsourcing crucial elements of GMP operations, such as presterilization. “The role of the supplier…
Article
Challenges and Trends in Biopharma Facility Design
It may also facilitate outsourcing of production to contract manufacturing organizations, which can, therefore, rapidly switch between customer projects and campaigns. Some contract manufacturing orga…
Article
Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
This week Process Development Forum speaks with Eric Langer, President and Managing Partner at BioPlan Associates, and the author of a number of biopharma studies, about the role of CMO’s in Bioproc…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…