Biopharmaceutical companies can develop entire end-to-end single-use production platforms and use them for commercial manufacture of their biological products. Single-use facilities are flexible, can be implemented quickly, and do not require the large up-front capital investments needed for stainless steel equivalents. However, single-use facilities must be supplied with a large quantity of high-quality consumables. Biomanufacturers should pay close attention to their supply chains for those consumables to ensure that they are robust, integral, and fully compatible with biological expression systems and products.
Simply attempting to ensure that single-use manufacturing platforms provide equivalent performance to stainless steel facilities is a missed opportunity. Innovations in the fields of process analytical technologies (PAT) and data analytics allow engineers to gain greater understanding and control of single-use processes. Those innovations deliver the combined benefits of more consistent production of high-quality product with improved productivity. Here I explore innovative PAT tools for control of critical process parameters (CPPs).