Ajinomoto Kohjin Bio

Ajinomoto Kohjin Bio (Saitama, Japan) is the first CMO company in Japan specialized in clinical grade culture media/buffer production for cell & gene therapy (CGT). We offer contract manufacturing services for liquid media and buffers under strict quality control in compliant with the Japanese PMDA’s Standards for Biological Ingredients. Our culture media / buffer CMO service provides clients with a fast track for CGT product development.

USP<1043> provides users with a guideline to qualify culture media for CGT product development. Following these guidelines, and the best practices described below, we are able to utilize our manufacturing expertise to provide clinical grade custom media to our customers.

Product characterization
Characterization of the product is crucial for clinical application. Our established raw materials management system enables us to provide well-characterized clinical grade custom media.  Additionally, we have the capability to offer customized characteristic analysis and stability testing upon request.

Animal Origin Free Facility
Having an animal origin free composition is a major requirement of clinical grade culture media, according to USP<1043>. Since our custom media manufacturing facility is dedicated to clinical grade production, we only accepting raw materials that are animal derived component free. In addition, our manufacturing processes are designed and operated in a manner than avoids cross-contamination with any animal derived components. Taken together, these efforts ensure we are manufacturing clinically applicable media for our customers at all stages of development.

Note: In this context, "clinical grade" media are defined as well-characterized ancillary materials, as referred in USP<1043>. Therefore, proper qualification is still required by users based on its risk level.

Capability from a small to large-scale production

The required quantity and the package of media/buffers are greatly dependent on the client's project stage. We provide flexible and scalable manufacturing services from basic research stage on to commercial production. Our flexible production capability allows clients to utilize high quality custom medium manufacturing services from an earlier stage, which accelerates client’s pipeline development 

Raw materials management & supply

Raw martials management is sometimes a very laborious process and requires significant resources. We perform raw material sourcing, qualification and management on behalf of our clients through a rigorous raw material control system, which is compliant with Japanese PMDA’s standards for biological ingredients. This allows our clients to efficiently allocate their valuable resources to the progress of their projects.

In addition, as Ajinomoto is the world’s leading supplier of amino acids, our clients can access our high-quality amino acids and growth factors which supports stable raw material supply and the consistent production of high-quality custom media.

Working flow