Process Characterization Studies

A well understood, well characterized process is a critical piece of your successful filing package, and ultimately, ensures your commercial process is robust and reliable. But process characterization studies can be time-consuming and expensive. How can you ensure your late stage timelines remain on track and on budget while still securing process characterization data that will serve you well throughout the product life cycle?

Bionova Scientific brings together a rare blend of deep industry experience and high-throughput infrastructure within an efficient, agile organization. We are uniquely positioned to deliver the technical horsepower you need combined with rapid timelines and smart workplans. Together, this yields successful upstream and downstream process characterization studies backed by full analytics that are tailored to your program, schedule and budget.

Technical Expertise

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.

FlexPCS: Because Flexible > Rigid

Sometimes, your in-house team or incumbent CDMO can’t accommodate every aspect of your PCS program while still meeting aggressive timelines. Bionova’s leaders have been in your shoes, which is why we developed our FlexPCS offering. FlexPCS lets you deploy the Bionova team to handle discrete pieces of your PCS project. We’ll work openly with your other teams to ensure you get the results you need when you need them.

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.