As product development proceeds in the field of cellular therapies, adequate product characterization remains a challenge for both IND Sponsors and FDA/CBER. Cellular therapy products are not considered to be well-defined products, and therefore the control and characterization of each stage of the production process helps to ensure product safety and consistency. Product characterization of cellular products includes demonstration of safety, plus determination of identity, purity, potency, and product stability. Development of appropriate specifications for each of these parameters is necessary for lot release, and also provides an important database of knowledge for addressing regulatory issues, such as lot-to-lot consistency and potential issues with product comparability, should the manufacturing process, or other aspects of product development, change over time…
Tag: <span>stability</span>
The baculovirus expression vector system (BEVS) is one method utilized for the production of recombinant proteins, and typically works without significant difficulties. However, some proteins are produced in insoluble forms, and degradation can occur. This article will focus on this degradation issue, and present a method to stabilize a protease-sensitive protein that has been produced at the 40-liter scale…