The Bionova team shares deep technical knowledge and a track record of advancing biologic candidates through Phase III and Commercialization. This experience was built at both contract service organizations and innovative drug developers, which means we also share a diversity of experience and have seen what works and what does not. Our team can design and execute an efficient process characterization study that will deliver the critical knowledge and data package you need, but without wasting critical time or resources.
Infrastructure & Capacity
Process characterization studies are inherently resource and equipment intensive. A scale-down model of your process must be run again and again to establish safe operating ranges for every critical process variable. Bionova maintains a suite of instrumentation and process equipment to support our client studies. For many instruments, we operate multiple platforms so we can be sure to achieve the best match to your analytical systems and process. Bionova also operates an extensive GLP upstream operation, so we can also generate product suitable for process characterization studies when needed.
Speed & Efficiency
Once your Phase III trial is underway and your process is locked down, every day is critical as you prepare your BLA. Bionova prides itself on being quick and responsive, but much of our process characterization speed is driven by smart design. We are able to identify key process risk areas early on and can develop a customized study design that minimizes unnecessary work and is cost effective while still satisfying regulatory requirements. Bionova also benefits from an agile, entrepreneurial culture: We have critical controls in place but are vigilant about keeping bureaucracy from slowing us down. Together, these efficiencies enable Bionova to deliver process characterization studies at a lower investment level than many larger CMO/CDMOs.
Legal & Regulatory Support
Bionova’s technical and quality teams have extensive experience working with the FDA and EMEA. We understand how to write a process characterization study protocol that will satisfy regulatory requirements. Our Quality systems provide secure and reliable data for your internal analysis and reporting, or the Bionova team has the Quality Engineering experience to perform full data analysis for you review.