The processes we develop to purify plant-made proteins are conducted using principles of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) for pharmaceuticals, with a focus on developing protocols that can be consistently replicated on a large, commercial scale under those cGMP conditions.
KBP’s technical team has worked on developing scalable processes for dozens of different proteins for a variety of commercial and governmental clients.
After the plants have produced the protein of interest, they are harvested and crushed to create a green-juice slurry. This liquid passes through filtration processes and sophisticated purification techniques to produce a final product. The entire process is enveloped in a rigorous quality-control framework, with analytical tests occurring at key points to verify process integrity.