Ian Burdick, Charter Medical, LLC
September 26, 2022
Even as the COVID-19 pandemic recedes, the supply chain difficulties it created have persisted. As suppliers at all
levels of the biopharma supply chain ecosystem recover, global demand for most biopharma materials continues to grow, creating widespread competition for those materials and supply chain challenges. Now more than ever, effective collaboration and communication between single-use solution (SUS) suppliers and biopharma customers will guide supply chain success.
Single-use suppliers have a unique spot in the supply chain. Since single-use suppliers operate between raw material suppliers and the final users of single-use solutions, they are uniquely positioned to see the weak links in the supply chain. With that level of vision comes the responsibility of fostering multi-level coordination and communication on all fronts. Understanding how the supply chain operates — including how challenges and solutions differ at each level — is vital to minimizing business, operational, and regulatory risk. Aggressively scheduled shipments, orders placed further in advance, supply agreements, and supplemental suppliers are a few examples of how to minimize supply chain risks.
Material Changes
A raw material change can quickly complicate supply of single-use products and can potentially cause a domino effect that impacts final production. For example, a change at the raw material supplier level (e.g., introducing a different resin) can affect several tubing and molded components across suppliers. Delay and regulatory issues stemming from material changes for single-use products can have a long-term detrimental impact on the therapy manufacturers that utilize these solutions. This type of change requires single-use suppliers to perform risk assessments to determine the optimal pharma/medical grade like-for-like material option that not only works for their own components and products, but for the entire biopharma industry.
So, what can be done to mitigate these delays and risks? Develop a plan for future product security. The first step to achieving this is to work with a SUS provider that thoroughly vets its raw materials suppliers. An expert single-use supplier has processes in place to:
- secure current supply
- understand the potential regulatory impact that a change can have downstream
- communicate timely change notifications to limit delays.
Every organization surrenders some level of control to its supply chain. But when it comes to raw material suppliers, savvy single-use providers understand which suppliers are susceptible to change and which ones can ensure the longevity of their materials for the end user.
Regulatory Standards
Limited biopharma industry standards around change management and notification can cause confusion and delay within the supply chain. This leaves biopharma organizations and the suppliers that support them uncertain on how to adopt standard practices that bring efficiency to their operations.
In recent years, the BioPhorum Operations Group (BPOG) “has been painstakingly developing best practices for SUT [single-use technologies] and work streams for extractables and leachables, [as well as] user requirements and change notifications…”1 The BPOG — a consortium, though not an official body — has released a guidance for customer change management and notification.2 The guidance characterizes changes based on their potential impact, to determine the appropriate level of customer notification.
As the process for determining and operationalizing standards continues, communication of change notifications will improve, ultimately leading to fewer delays and a more effective supply chain. In the meantime, partnering with a communicative and quality-driven single-use provider can mitigate further delays and production setbacks.
Multiple Supply Streams
As biopharma manufacturers build out their process, sourcing the parts to be able to produce a therapy or final product becomes critical. Developing sourcing redundancies within those processes is a key step to ensuring uninterrupted production.
Using secondary single-use suppliers can further reduce the risk of production halts. Sourcing redundancy might mean approving two manufacturing sites or approving two different companies to supply materials. Even using multiple distributors can extend the supply chain, even if just temporarily. Multiple sources of single-use solutions can provide the agility needed to be able to produce consistent product without needing a constant pulse on the overall supply chain.
Agreements and Shipments
Understanding the capacity needed for single-use solutions can be challenging, as biopharma clients can’t always commit to longer-term supply agreements or large ordering volumes. For example, when a therapy in development doesn’t meet desired clinical outcomes, the therapy manufacturer immediately no longer needs that influx of single-use products for the manufacturing process. This can easily disrupt the forecast and supply chain. In lieu of an agreement, aggressively scheduled shipments and orders placed well in advance can provide the time needed to secure the supply chain.
Real-time communication in both directions is vital to mitigating risk for all parties involved.
The strongest approach to mitigating supply chain risk is multiyear supply agreements — ideally those that extend beyond three years. Such agreements allow a SUS provider to operationally prepare and insulate its supply chain in terms of staffing, shipment, and delivery of single-use products. The SUS provider’s focus then can be placed on securing — and sharing — the most relevant and accurate supply information, such as delivery timeline and change impact assessment.
Keys for Stabilizing Single-Use Supply Chains
In any organization, supply chain issues tend to create a ripple effect, wherein a single event can affect numerous partners and operational areas — and it can be a struggle to restore balance. If poorly executed, recovery can be painfully slow, taking months or years to reestablish a strong supply chain balance. Approaches like sourcing secondary suppliers and implementing supply agreements can decrease the risk of supply chain issues within biopharma processes and insulate end users when issues occur.
Ultimately, an experienced SUS partner can provide a stabilizing middle-ground presence, bridging the business, communication, and regulatory gaps between raw material suppliers and biopharma end customers. The most successful supplier-customer relationships provide line of sight from all sides when it comes to the supply chain: shifting lead times, material changes, and capacity planning/forecasting. Ask questions up front when getting to know a supplier partner.
Resources
- Wong, Ken, et al. “BPOG Five-Year Vision for Single-Use Technologies.” American Pharmaceutical Review, 16 Mar. 2017, https://www. americanpharmaceuticalreview.com/Featured-Articles/335494-BPOG-Five-Year-Vision-for-Single-Use-Technologies/.
- https://www.biophorum.com/download/aguide-to-the-classification-of-changes-to-sus/
About The Author
Ian Burdick is the Associate Director of Product Management at Charter Medical in Winston-Salem, North Carolina. Ian manages Charter’s product portfolio and provides cross-functional leadership to strategically develop new single-use solutions for the various markets that Charter Medical serves. Ian leverages his 10 years of experience in global sourcing, distribution, and contract manufacturing to bring unique insights into meeting the needs of the biopharmaceutical market and many others. Ian has a B.S. from Western Michigan University and an MBA from the University of North Carolina.
About Charter Medical, LLC
Charter Medical, LLC has more than 30 years’ experience developing and providing specialty single-use products for bioprocessing, advanced therapies, and blood management applications delivering solutions to the biotechnology and pharmaceutical markets. Our 16,000 square feet of cleanroom space located in Winston-Salem, NC, is ISO 13485 certified and FDA registered, with a focus on designing and supplying single-use solutions for cell growth, frozen storage, and biological fluid handling. Custom product design services are available for clients who need specialized single-use products for biomanufacturing. Our team of engineers will work with you to develop the best solution for your specific requirements. Charter Medical is committed to providing quality products and services with an experienced staff dedicated to exceeding customer expectations from product development to delivery and implementation. Charter Medical works closely with our sister companies, Secant Group and SanaVita Medical, to provide essential products and services to life science companies. Through integrated research and development activities, we are helping to bring new technologies and therapies to market.