Quality specialist is key in any biopharmaceutical development team

Meet the Expert: Margreet, QA specialist

The ability to translate biopharmaceutical research into products is known to have a high failure rate. A staggering 75% of published pre-clinical data cannot be reproduced or validated to allow further product development¹. I believe that the only way to prevent such disappointments both scientifically, as well as commercially, is to ensure that a Quality Assurance specialist is involved from day one in any R&D program aimed to deliver a product to be used in humans. By incorporating Quality in the early stages of biopharmaceutical development, correct resources will be selected (GMP compliant raw materials, production cell lines and scalable systems) and pivotal support documentation will be laid down that will prevent unnecessary delays in reaching the patient.

Quality Assurance in R&D

The regulatory authorities request any organization, interested to take a candidate new medicine in man, to deliver a so-called “investigational new drug” dossier (IND) for review and safety assessment by the authorities. In essence, an IND dossier must answer three pivotal questions, i.e., (I) what scientific rationale in support of testing the candidate medicines in humans is available? (II) Has a process been established that allows robust and reproducible manufacturing of the candidate medicine? (III) What safety data has been generated that allows a solid risk assessment on the candidate medicine to be tested in humans.

Unfortunately, many R&D programs are executed with a strict focus on scientific rationale, neglecting robust process and safety data. A QA expert involved in the early stages, will ensure that any step taken in generating the scientific rational goes hand-in-hand with all other IND dossier requirements. This requires, for example, experience and broad knowledge to provide guidance on selection of GMP certified raw materials or input on the development of manufacturing processes to ensure proper selection of scalable, GMP compliant equipment.

At Batavia Biosciences, the QA department is involved in R&D project discussions as a pivotal resource from day one. Without a doubt, this is a major contributor to the fact that Batavia Biosciences has a 100% successful IND support track record. How does QA help ensure the fastest way into the clinic?

• Planning phase: Without exception, every customer wishes to learn how the time-to-clinic can be shortened or investments in product development can be postponed. Batavia Biosciences’ QA assists the technical staff and the sponsor to develop a detailed product development plan, whereby risk-based decisions on the optimal path to the clinic are argued, laid down and locked-in.
• One documentation system: In the R&D environment all selected materials and equipment are suitable for GMP manufacturing. This way, the developed process is GMP compliant, and directly transferable to a GMP facility without repeating any experiments. In addition, we use the same documentation system in R&D as we do in GMP.
• Avoid tech transfer: Batavia Biosciences’ laboratory staff members, working in R&D are trained according to the Quality system implemented by the QA department. Therefore, the same team that develops the production and purification processes in an R&D environment is fully trained and thus able to take the project into GMP. This way we avoid time-consuming tech transfer.

¹ Begley & Ellis, Drug Development: Raise standards for preclinical cancer research, 2012, Nature 483, 531-533

As a company dedicated to help bringing biopharmaceuticals to the market at higher speed, with reduced costs, and with a higher success rate, Batavia Biosciences has vast experience in developing GMP compliant upstream and downstream bioprocesses and corresponding product specific assays. With our team of experienced QA specialists, we are well equipped to take on any challenge associated with biopharmaceutical development