![]() ![]() Starting in mid-2020, the bioprocessing industry performed an impressive and rapid response to transfer and scale-up despite lack of clarity on basic information (e.g., on final formulation, stability data, dosage, and volumes). This experience has, of course, accelerated implementation of remote working practices, previously seen as having significant blockers. One company with seven sites, all of which needed to be kept open, developed new ways of working. People and ways of working:Impact of COVID-19ĭuring the COVID-19 crisis, it’s been a challenge simply to keep manufacturing facilities open and running. Recognizing how interconnected the bio/pharma industry is, and how shortages in one area affect other medicines, is critical to defining any solution for improving materials distribution and logistics. There’s the risk of over-ordering and creating safety stocks, which creates inefficiencies across the industry. With suppliers setting priorities, companies are receiving notifications (e.g., single-use materials, resins) to re-confirm and re-route deliveries. There are some key materials (e.g., vials, syringes, stoppers, seals) from a limited number of suppliers, which limits flexibility to increase the supplier base. ![]() For users, it is not straightforward to bring on and qualify new suppliers. As demand has increased considerably, old methods are now ineffective. Suppliers are used to having known, predictable demand. This ‘emergency’ supply chain management is new to the industry and is evolving. The common view was that one needs to see the whole picture of demand with critical stock available for everyone to access. Where suppliers can’t supply, they’re making priorities. And while some suppliers have the ability to expand with flex-capacity-a glass vials supplier is increasing output by five times-most do not. Delays for delivery of some of these materials are forecast to be 12 or 15 months sterile filters delivery times have been extended from 2–3 months to 9–12 months lead-times also have extended for media and chemicals. From basic raw materials (e.g., buffers, resins, sodium chloride), to consumables (e.g., single-use bags, tubing, sterile filters) and fill/finish (e.g., vials, stoppers)-these all need to be available and in place for the system to function. While this has not been entirely unexpected, the delays and challenges have stressed the supply chain severely. The most critical factor raised in regard to COVID-19 vaccine manufacturing has been the availability of materials. The following are key challenges for COVID-19 vaccine manufacturing and supply chains. BioPlan Associates interviewed front-line bioprocessing decision-makers to assess and highlight the general bioprocessing, raw materials, and supply chain challenges associated with COVID-19 vaccines, together with need for approaches to moderate risks and avoid delays. Monumental challenges are facing manufacturers, contract development and manufacturing organizations (CDMOs), and suppliers during the evolving situation in the manufacture of COVID-19 vaccines. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |