- O Nás
ZETA designed, produced, commissioned and performed the qualification of a cGMP- and FDA-compliant, fully automated bioreactor for manufacturing monoclonal antibodies (mAb). The bioreactor extends an existing production setup by adding a scale-up stage, which became necessary because of a licence agreement for a new product. The design of this intermediate stage had to be precisely coordinated with the customer in order to ensure consistency of processes between the existing system and the new system. This resulted in strict requirements for documents, the design and the components that could only be fulfilled by consulting with the customer on every detail. The licence agreement also created great urgency to have the system in operation as soon as possible.