We develop scalable, robust and GMP-compliant manufacturing processes for viral vectors.
At Batavia Biosciences, we operate under three guiding principles in developing viral vector products. These principles are briefly outlined below:
The development of a production protocol that allows smooth entry into phase-I and phase-II clinical trials starts with a thorough understanding of the foreseen commercial manufacturing process. Thus, all raw materials, equipment, and process architecture designed or developed for clinical manufacturing must be seamlessly able to be extrapolated to commercial scale. Should this not be taken into account, there is a serious risk that at a later stage, a process will need to be substantially re-designed. This can be a trigger for regulatory authorities to demand new clinical trials to demonstrate safety and efficacy. We have a long-standing track record in building realistic and detailed product development plans in the viral vector arena to help choose the proper path in developing the process and the resulting product, getting it right the first time. This principle is deemed key in the viral vector field when markets, patient populations, and dosing regimens for many of these types of products are constantly in flux.
To quote Yogi Berra (American Baseball player):
“If you don’t know where you’re going… You will end up someplace else”.
Manufacturing costs need to be well controlled. Therefore, high on the priority list when designing manufacturing processes are:
These are all critical drivers of economics. In fact, it is deemed crucial that all these parameters are carefully evaluated and mapped upfront, so that optimal output parameters and acceptable bandwidths are known. These parameters will then be used to determine success or failure during process development (design space). We offer in silico cost modeling services and have an excellent track record in developing processes aligned with pivotal economic drivers. We have amassed a portfolio of technologies and capabilities and this helps to reduce cost and timelines. For instance, we have designed strong synthetic promotors to ensure high expression of genes inserted into viral vector backbones, either with general activity or cell- or tissue-specific activity. Also, we are very experienced in vector backbone modification to allow rapid DNA design, synthesis and delivery times. In addition, we have developed different feed strategies to increase cell density of packaging cell lines, thereby substantially increasing viral vector yield. We have identified novel resins and ligands that provide strong binding and allow for high purification recovery of the biologically active vector. Finally, we have ample experience with product stability testing and can provide support in the selection of optimal formulation buffers.
To quote Lucius Seneca (Roman philosopher):
“Luck is a matter of preparation meeting opportunity”
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 contributing factor to our success in IND support. To demonstrate the importance of early QA involvement, we share three early QA initiatives that are drivers of ensuring the fastest route to the clinic.
Planning phase: Without exception, every customer wants to know how to shorten the time to clinic or when investments in product development can be postponed. Our QA department assists the technical staff and the customer to develop a detailed product development plan, in which risk-based decisions on the optimal path to the clinic are justified, laid down and locked-in.
One Quality Management system: In the R&D environment, all selected materials and equipment are suitable for GMP manufacturing. In this way, the developed process is GMP-compliant from the start, and directly transferable to a GMP facility without the need to repeat any experiments. In addition, the Quality Management system used in R&D is identical to the Quality Management system used in GMP.
Avoid internal tech transfer: Our laboratory staff members working in R&D are also trained and qualified to work in a GMP environment. Therefore, the same team that develops the production and purification processes in an R&D environment is also fully trained and able to seamlessly take the project into GMP. In this way, we avoid time-consuming internal technology transfer processes that would be otherwise necessary.
To quote Walter Disney (American film producer):
“Always fight for quality… whether giving or receiving”