Following the wave of successful commercial monoclonal antibody products, various forms of antibody fragments are now becoming an important class of next-generation therapeutic proteins. However, due to the lack of an Fc region, these antibody fragments cannot be captured with most engineered Protein A affinity ligands. Amsphere™ A3 Protein A ligand, however, exhibits a high affinity for VHH single-domain antibodies. Click here to read more about Purification Of Antibody Fragments And Single Domain Antibodies With Amsphere™ A3 Protein A Resin.
Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone else is exhibiting a form of the psychological bias known as the bandwagon effect,in which they go along with the rhetoric because everyone else is.
Since 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the U.S. How does the rise of the China biosimilars market fit this established picture?
The 2019 PDA/FDA Joint Regulatory Conference will highlight the evolving regulatory landscape and provide insight into how global companies are addressing regulatory challenges. Hear directly from senior FDA officials about program-specific initiatives and compliance updates. There will also be networking opportunities and an exhibition showcasing products and services to help improve your company’s product quality and manufacturing processes. Register now.