As the ongoing COVID-19 pandemic has taught us, it is essential for global biopharmaceutical manufacturers to manage their end-to-end supply chains, taking into consideration the supply of raw materials, purification consumables, and chromatographic resins. Events like the pandemic remind us of how vulnerable today’s supply chain can be and just how important each step—and each player—is to our global health.
Over the past two decades, the supply chains of drug manufacturing companies have become longer, more intricate, and increasingly fragmented. In fact, supply chain complexity was identified as a root cause of drug shortages in a report released in 2019 and updated last year by the interagency Drug Shortage Task Force, run by the FDA. And supply chains are becoming more complex, risking additional complications, as companies move more production overseas and rely more on the work of contract manufacturers.
Investment, innovation, and risk diversification are required to allow drug manufacturers to swiftly increase production. One of the best methods to facilitate such an increase, while simultaneously safeguarding against supply chain disruption, is implementation of a distributed manufacturing plan.
There are three essential components of a distributed manufacturing plan that should be considered to help ensure a robust supply chain and lessen supply interruption risk: developing a global manufacturing footprint; utilizing more than one manufacturing location; and maintaining site-specific business continuity plans.
A global strategic manufacturing footprint is key
Most biopharma purification and filtration vendors make fundamental products like filters and chromatographic media at a single location. These vendors have responded to their customers’ need for secure supply chains by installing additional capacity and qualifying alternate sources of raw material supply. This strategically disperses risk while still allowing vendors to have effective global reach.
3M produces over 60,000 products in more than 200 factories in 41 countries. In 2012, 3M began a program to streamline its manufacturing and supplier networks to reduce complexity. 3M’s long-term plan is to have fewer, larger, more-efficient plants and to locate production in strategic “super-hubs” (places where multiple, related businesses are co-located) that are capable of making scores of products for particular regions of the world.
For 3M’s Separation and Purification Sciences Division, part of the company’s Health Care Business Group, the global manufacturing footprint strategy includes leveraging the company’s super-hubs. This allows the Division to install smaller, effective, and distributed manufacturing facilities in specific geographies while responding to the supply chain security requirements of our customers in the global pharmaceutical industry.
Location, location, location
A second element of risk diversification to be considered is the manufacture of individual product families at more than one facility location. When products are made in more than a single location throughout the world, the downstream supply chain and customer impacts can be minimized if a catastrophic event occurs at a single manufacturing site.
For example, 3M’s Zeta Plus™ products, used to make life-saving plasma therapies, are manufactured in several locations throughout the globe, strategically located where demand for them is highest. Production of these items in the United States, Europe, and Australia allows for a higher level of security of supply for thousands of products and pharmaceutical end-product manufacturers.
When it comes to responding to an enormous uptick in supply demand for critical components to vaccines and treatments, as was the case in the COVID-19 pandemic, having multiple manufacturing locations can lessen the risk to continuity of supply and may provide surge capacity options.
Reliability by design: Site-specific business continuity plans
While geographically dispersing sources of supply helps reduce risk, it is recommended that each location in the supply chain additionally have a business continuity plan (BCP) to supplement normal manufacturing operations and to address crisis management situations and local emergency response requirements.
BCPs can be another effective tool to minimize supply interruption and allow a site to respond more effectively to unplanned events. Plans should, on some level, integrate employee input and anticipate various contingencies.
All players in the biopharmaceutical industry making therapeutics—especially during times of global demand and crises like COVID-19—should consider ensuring risk diversification and safety within their unique manufacturing models. Co-locating biopharma product manufacturing in hubs where other healthcare products are made can give vendors the opportunity to utilize common infrastructure, shared services for human resources and administration, and common quality assurance systems. This can give vendors the flexibility to have the scale required to meet global demand while keeping manufacturing operations geographically distributed.
This approach can mitigate supply chain risks required by the biopharma industry and regulators, while avoiding the expense of qualifying alternative vendors for pharmaceutical companies.
A distributed manufacturing strategy can enhance end-to-end supply chain security and allow biopharma vendors to offer key products at locations that are geographically closer to their pharmaceutical customers. Establishing a global footprint, developing multiple manufacturing locations for similar product families, and creating site-specific business continuity plans should be considered for creating an efficient and effective supply chain.
Robert Befidi is president of the Separation and Purification Sciences Division at 3M.