Overview
Biotherapeutics have a successful record for treating diseases and account for almost half of new drug approvals in the U.S. These therapeutics are produced in biological systems and thus present unique manufacturing challenges to achieve the yield and purity needed for an efficacious and safe treatment. Affinity ligands, which are designed to target a specific molecule, are commonly used during the biotherapeutic manufacturing pipeline to both capture and analyze the target molecule.
In recent years, biotherapeutic versatility has expanded. Manufacturing and analytical processes need to be tailored to each individual biotherapeutic, which can be challenging because not all molecules have established or commercially available chromatography resins. Development of affinity chromatography resins, including those based on the variable antigen-binding region (VHH) of camelid heavy-chain only antibodies, have helped improve protocols for biotherapeutic development and manufacturing. This whitepaper from Thermo Fisher Scientific highlights the versatility of these affinity ligands and explores how they can support the development of diverse biotherapeutics.
Key Objectives:
- Why affinity chromatography is important in the production of biotherapeutics
- How decisions around affinity ligands can affect the manufacturing and analytical process
- How affinity ligands can facilitate the purification and development of diverse biotherapeutics
- How affinity ligands enable analytical methods that aid in biotherapeutic development