Even before COVID-19 upended our lives, a growing pipeline of niche drugs targeting smaller patient populations was driving dramatic changes across the biopharma landscape, leading to a wide range of supply chain challenges. Many of these drugs are biologics, where the process is the product, and even minute variations can impact performance. Therefore, securing an uninterrupted supply of equipment and high-quality raw materials is essential for producing these products with the utmost safety and efficacy.
Now, unprecedented levels of demand for materials and manufacturing capacity exacerbated by the global pandemic are putting incredible strain on the biopharmaceutical supply chain, calling on suppliers to reevaluate their own risk-mitigation strategies in order to evolve into the agile and dependable organizations the industry so desperately needs in this “new normal.”
Preventative measures to assure quality of supply can avoid shortages in equipment and consumables, thereby establishing a foundation for consistent quality, change control management, and business continuity planning. While fallout from the ‘bullwhip effect’ could make component shortages inevitable, vendors must empower their partners with alternative options, such as supporting opportunities to simplify product validation and enhancing their regional presence to ensure they can continue production. This includes capacity expansion, second supplier validation, and assurance of supply programs for consumables.
Download the complete article to learn what your supplier should be doing to de-risk the overall supply chain and help secure the availability and quality of your biologic as well as safeguard its path to market.