An engineering batch is made prior to full scale cGMP batch, to fine-tune the process, finalizing batch production records and finalizing a process control strategy.
Cerbios considers the engineering run to be an integral part of the development effort. Cerbios’ policy is to assure a successful process, avoid deviations and get the high-quality material to its client on time. For this reason, a manufacturing batch, prior to full scale GMP batches, at the exact same scale and equipment, is made in order to pave the way towards process validation.
This helps with process understanding and considerably reduces potential sources of problems, minimizing the risk of failure. The material provided can be used for pharmacodynamics and pharmacokinetics studies in animals, drug product development and/or toxicology studies. Reference standard material is provided with analysis and release documents.