By Serena Fries Smith
The development of a robust and consistent bioprocess requires a systematic and risk-based approach to identify the right process parameters and raw materials.
This is a very exciting time in the biopharmaceutical industry. While we continue to see companies investing in new therapeutic proteins and biosimilars, we are also seeing an emergence of gene and cell therapy treatments. Each of these therapeutics present unique complexities in process development, but for all, the development of a robust and scalable bioprocess is critical to process consistency and long-term manufacturing success. Ultimately, it’s all about developing a quality process that delivers the desired performance and product every time.