A key differentiator of KBP’s process is the use of plants instead of other traditional methods to create complex-protein products. Using plants allows for greater accuracy and speed in production. The tobacco plants we work with become manufacturing centers that produce the proteins we extract and purify to manufacture vaccines and other pharmaceuticals.
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.
Plants are seeded, germinate and grow before the genetic construct representing the protein of interest is inserted. With this transformation, plants incubate for several days during which they are reproducing the target protein. At this point, 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.