We develop scalable, robust and GMP-compliant manufacturing processes for recombinant proteins.
At Batavia Biosciences, we operate under three guiding principles in product development, be it viral vectors, viral vaccines or protein and antibody 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 needs to be substantially re-designed which can trigger 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 recombinant protein arena to help choose the proper path in developing the process and the resulting product, getting it right the first time.
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 evaluated carefully and mapped upfront, so that optimal output parameters and acceptable bandwidths are known and 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 considerable portfolio of technologies and capabilities and this helps to reduce cost and timelines. For instance, we deploy our STEP® vectors to ensure high expression in stable mammalian cell lines. Also, we use our SCOPE® technology to rapidly manufacture high yield proteins in E. coli. In addition, we have developed different feed strategies to increase cell density thereby substantially increasing protein yield. We have identified novel resins and ligands that provide strong binding and allow for high purification recovery of the proteins. 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 and IMPD 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. This helps to avoid time-consuming internal technology transfer.
To quote Walter Disney (American film producer):
“Always fight for quality… whether giving or receiving”