By Jianfang (Sophia) Li, Ph.D., Manufacturing Sciences and Technology Group, Grifols
Analytical methods are essential tools to demonstrate successful process transfers and to evaluate the final protein product. Rapid and successful transfer of recombinant protein analytical assays plays a key role for CDMO projects and establishing analytical methods early.
Based on project-specific needs, a variety of analytical assays are employed to evaluate the potency, strength, purity, impurity, and other relevant attributes of the product. These are crucial metrics for determining whether the manufactured product meets the client’s expectations and offers safe, efficacious treatment to patients.
From a project timeline perspective, it is important to establish analytical methods early to support a rapid and successful process transfer. As a result, the successful and efficient transfer of analytical assays is vital for the overall success of the project. It establishes a solid foundation and fosters mutual trust, which in turn promotes further collaboration between CDMO partners. Learn how a CDMO that is experienced in producing and characterizing diverse recombinant proteins is essential when building a strong foundation for accelerating the successful transfer of recombinant protein analytical assays.