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…

The preceding articles have shown how biopharmaceutical companies increasingly are adopting single-use manufacturing technologies for commercial production facilities as their confidence grows in the material science, supply chains, and robustness of single-use systems. Single-use suppliers can support adoption of end-to-end process platforms in commercial manufacturing settings with dedicated teams of experts in process development, engineering, and regulatory support. Advances in process analytical technology (PAT) are providing engineers with greater information on conditions within their single-use bioprocess platforms to allow for…

The development and launch of new biopharmaceutical products is a very challenging and risky process. Sponsors must get their products into clinical testing as quickly as possible to beat their competition and take the greatest share of the market. Yet that need for speed must not lead to companies launching products with inefficient manufacturing processes that ultimately will leave them vulnerable to attack from low-cost competition. Single-use systems have been a significant enabling technology for companies developing new biologics because…