We develop scalable, robust and GMP-compliant manufacturing processes for recombinant proteins.
At Batavia Biosciences, we adhere to three guiding principles in developing processes for recombinant proteins. These principles are briefly outlined below:
Process development first time right
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 expected commercial manufacturing process. Thus, all raw materials, equipment, and process architecture designed or developed for clinical manufacturing must be able to be seamlessly 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 which 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 detailed and realistic product development plans for a variety of products including many different recombinant protein products. Such a plan provides a road map to help management of our customers to choose the proper path in developing the process and all other steps involved in bringing the product to the patient. Getting it right the first time is critical to ensure building shareholder value and is 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”.
Cost-efficient protein production
Manufacturing costs are one of the main cost drivers for a product. Therefore, it is important to establish a cost-efficient manufacturing process. To gain control over this process, when designing manufacturing processes high priority is given to:
- Efficient pre-culture process to allow optimal use of the production bioreactor
- Optimal process yield obtained in bioreactors (USP)
- Optimal purification recovery (DSP)
These are all critical drivers of the Cost of Goods. In fact, it is crucial that all these drivers are carefully evaluated, 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 a long-standing track record in developing processes aligned with pivotal economic drivers. We have amassed a portfolio of technologies and capabilities that aid the reduction of the Costs of Goods and reduction of development timelines.
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 directly transferable to a GMP facility without the need to repeat any parts of the final process. 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 R&D is also fully trained and able to take the project into GMP. In this way, we avoid time-consuming internal technology transfer processes that would otherwise be required.
To quote Walter Disney (American film producer):
“Always fight for quality… whether giving or receiving”