Why does it take so much time between awarding a CDMO contract and initiating the first activities at the CDMO? Once a project is granted, there are activities that you as the sponsor company can perform before, at, and after the traditional kickoff meeting for best success.
The biotech plant of the future will use in-line monitoring (ILM) and real-time release (RTR), which includes process technology, operational systems, facility design, and construction innovations that will increase capacity and enable efficient processes. This article is a guide to adopting that vision.
Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.
SEC, also known as gel filtration, can be used for preparative and analytical studies of your protein. But how do you know which parameters give you the best resolution of your protein mixture?
What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.
