Sterile Injectables Supply on Demand
Lessons learned: achieving a more resilient sterile injectables supply chain
The last year has seen significant swings in supply and demand for raw materials and commodities relating to the development, production, and fill/finish of sterile injectable drug products.
Demand for supplies of materials for sterile injectable production, such as glass vials, filters, and stoppers has soared, which has resulted in shortages that have impacted the manufacturing of other drug products. In addition, there have been increased quality concerns associated with these high demand materials.
The shortage of high-quality materials and increased lead times has led the industry to take steps to safeguard supply chains against an influx of lower quality alternatives. These may fail safety inspections, with implications for the integrity of any product packaged inside.
There are lessons to be learned from recent industry events which the industry must take on board. Here are some that we have identified to help build a more resilient sterile injectable supply chain.
Lesson 1: work with customers to agree to purchase safety stock
Customers’ forecasts typically trigger orders for raw materials or commodities in a “normal” global trading environment.
In times of restricted supply, lead times for these materials may change dramatically. With these lead times in mind, it is crucial for drug companies and their contract development and manufacturing organization (CDMO) partners to work together to explore how continuous supply can be maintained and agree upon expectations.
During the last 12 months at Pfizer CentreOne, we proactively reached out to customers about placing orders for vials, stoppers, filters and other materials to tackle supply shortages before they became problematic. We offered customers the ability to carry safety stock of their components to mitigate patient impact, safeguarding the people relying the most on a sustainable supply chain.
Lesson 2: Establish protocols for multi-line or multi-site approval
Multi-line or multi-site approval for products is key to enhancing resilience in the future. Currently, some customers have elected to only qualify one fill line. Limiting product qualification to certain lines can limit a company’s capacity to react to rapid market changes. This is particularly acute in the injectables space because the lead time associated with qualifying a new line or site is prohibitive when trying to manage a near term supply challenge.
Companies should take the steps required to allow the filling of products at different sites or alternative filling lines in the future. This will free them from potential capacity restraints for specific products and provide the ability to scale up production capacity if and when needed.
This approach will require having regulatory approval in place before it is urgently needed, allowing companies to respond quickly to increases in demand and to meet patient needs.
Lesson 3: Flexibility is king
Drug companies and their CDMO partners need to ensure that their operations and their supply chains are flexible and agile.
At Pfizer CentreOne, we pride ourselves on our flexibility. During the recent pandemic, we took steps to maximize capacity and resources for our customers to help them deliver their priority products to market. We also worked with customers to produce products at other Pfizer CentreOne sites, streamlining approval processes to circumvent traditional barriers to such manufacturing transfers.
In addition to internal agility, it’s important to ensure supply chain flexibility. We are working with customers right now to diversify their supply chains to ensure the security of vital supplies in the future. In the past, many raw materials were single-source, however, we are committed to supporting customers as they expand their supplier base to avoid future disruptions.
Time to act
The global pharmaceutical industry is continually evolving, however the events of the pandemic brought about an urgent need for change. Responses to the changes have taught us vital lessons that we must continue to heed to ensure that we are ready for future events that may impact the market.
At Pfizer CentreOne, we are committed to continuous improvement and working closely with our customers to create a more resilient pharmaceutical supply chain. By working in collaboration with our customers, we have no doubt that we will be ready for whatever lies ahead.
To find out more about how Pfizer CentreOne can support your sterile injectables project, contact us today.