Written by Expert: Margreet, sr. QA specialist
The ability to translate biopharmaceutical research into products is known to have a high failure rate. A staggering 75% of published preclinical 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 in biopharmaceutical development from day one. This counts for 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. Examples of such resources are GMP compliant raw materials, production cell lines and scalable systems. Also, pivotal support documentation prevents unnecessary delays in reaching the patient.
Quality Assurance in R&D
The regulatory authorities request any organization interested to take a candidate biopharmaceutical to the clinic, to deliver a so-called “investigational new drug” dossier (IND). The authorities will then review de dossier and do a safety assessment. In essence, an IND dossier must answer three pivotal questions:
- What scientific rationale in support of testing the candidate product in humans is available?
- Has a process been established that allows robust and reproducible manufacturing of the candidate biopharmaceutical?
- What safety data has been generated that ensures a solid risk assessment?
Unfortunately, many R&D programs are executed with a strict focus on scientific rationale. Thus, robustness of the process and safety data is neglected. A QA expert involved in the early stages, ensures that any step taken in generating the scientific rational goes hand-in-hand with all other IND dossier requirements. This requires experience and broad knowledge on selection of GMP certified raw materials and knowledge of the development of manufacturing processes to ensure proper selection of scalable, GMP compliant equipment.
At Batavia, 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. This plan provides risk-based decisions on the optimal path to the clinic.
- 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. It also meand that the process is 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 is able to take the project into GMP. This way we avoid time-consuming tech transfer. Additionally, the operators involved in analytical development are also trained for executing the assays for Quality Control, avoiding tech transfer of the assays.
1 Begley & Ellis, Drug Development: Raise standards for preclinical cancer research, 2012, Nature 483, 531-533
We are dedicated to help bring 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
