Process Development Services
Our Process Development (PD) Department provides extensive mammalian and microbial pharmaceutical R&D service offerings that are both stand-alone and cGMP-enabling. Services include cell line development, microbial strain development, research cell bank production, process development, process optimization using statistical Design-of-Experiments (DoE), technology transfer, scaled-down model development and process characterization using a QbD framework.
All customer projects are tailored to match the required scope and specific clinical phase. Our unique commercial and in-house Mammalian and Microbial platform processes enable us to achieve efficient movement through early development programs and into clinical production and commercialization.
Process Development Key Benefits:
- Maximizing the production capacity of a therapeutic platform
- Creating a sustainable, reproducible and transferable manufacturing system
- Reducing manufacturing costs
- Extending intellectual property protection or proprietary know-how through innovation
- Satisfying the regulatory requirements necessary for FDA approval
We can provide a complete package or stand-alone services for PD and analytical development critical to completing a successful biologics manufacturing campaign, including:
- Cell Culture Development with bench scale non-cGMP production
- Recovery and Purification Development
- Analytical Development and Validation
- Cell Line Development
- Final Product Fill/Finish Development
- Process Troubleshooting
- Technology Transfer
Our process development team also has specific expertise in recombinant proteins with complex glycosylation requirements, an important component of many current therapeutic products. VxP Biologics has experience in the development and production of numerous products now introduced into the worldwide market.