Moving From a Handshake to a Strategic Supplier Relationship

Contract manufacturing is evolving into a full-service industry. To succeed in delivering for cell and gene therapy companies, that full service must include a reliable supply chain that can harvest and deliver quality starting material when and where it is needed.

Contractual strategic supplier relationships that go beyond the typical arm’s length relationships between contract manufacturers and vendors are key to creating a true full-service offering in the cell and gene therapy ecosystem.

The benefits of contractual strategic supplier relationships
The cell and gene therapy market has two main segments: autologous and allogeneic therapies. Autologous therapies use starting material that comes directly from a patient. Allogeneic therapies use starting material that comes from a healthy donor.

While there are distinct differences in the supply chain challenges between the two, both benefit from contractual strategic supplier relationships in the reliable, safe, and on-time collection and delivery of starting material.

With a strategic supplier relationship, the companies have an opportunity to:

• Set mutual goals and agree to specific milestones and timing the organizations will hit;
• Memorialize what level of investment both parties will make in developing a solution;
• Create a joint product development road map; and
• Build solutions that both companies can implement more quickly with fewer failure points.

This is important because implementation timelines for clinical studies and commercial launches are currently long as manufacturers and their vendors try to figure out how to best work together. Extra months for implementation can make the difference between a patient receiving a potentially life-saving therapy or not.

Strategic supplier relationships allow companies to get ahead of foreseeable problems and implement solutions quickly.



Integrations that are possible with a strategic partnership
The strategic partnership between Be The Match BioTherapies and Lonza is a good example of how a supply chain vendor (Be The Match BioTherapies) and a contract manufacturing organization (Lonza) can move beyond traditional agreements. The two organizations are working towards integrating the acquisition of cellular starting material, therapy manufacture and therapy shipment into a single service offering.

Integrations between organizations can range from very sophisticated, such as integrating IT systems and adhering to shared quality systems to streamline day-to-day operations, to less sophisticated, such as dedicating personnel from each company to a single client.

Getting ahead of known roadblocks in the on-time delivery of cellular starting material
Whether the cell or gene therapy being manufactured is allogeneic or autologous, the supply chain into and out of the manufacturing facility is time sensitive and complex. Manufacturing slots are in high demand.

Delayed delivery could mean a manufacturing slot is no longer available.

While some delays—such as a change in a patient’s health status—are unavoidable, companies can get ahead of other known problems through strategic supplier relationships.

For example, a U.S. cell procurement, shipment to Europe for therapy manufacture and shipment back to the U.S. for therapy delivery is a common supply chain. However, the greater the distance traveled and the more borders the cells need to cross, the greater the risk of error and delay.

A partnership like the one between Be The Match BioTherapies and Lonza allows the two companies to collaborate very early in the process to determine what an ideal supply chain will look like based on the locations and capacity of Lonza’s manufacturing facilities and planned cell harvest facilities.

Even prior to that, the Be The Match BioTherapies logistics team can work with the Lonza team on a consultative basis to determine ideal locations for autologous or allogeneic cell harvest to minimize the risk of failed or delayed deliveries of cells to Lonza’s manufacturing facilities. It can be as simple as determining which shipping lanes most reliably feed into the manufacturing location.

It may sound counter intuitive, but this kind of simple planning often doesn’t often occur with a traditional arm’s length vendor relationship.

Creating a reliable pipeline for allogeneic donor starting material
Procuring allogeneic cell and gene therapy starting material has its own unique challenges that a strategic supplier relationship can help overcome.
Allogeneic source material relies on healthy donors. That donor capacity is not unlimited. Finding the right set of donors can be difficult, particularly if the cell or gene therapy requires donors with unique characteristics and if high volumes of those donors are required.

Having a contractual strategic relationship with a donor material supplier offers an avenue through which to plan for and secure high volumes of complex donor material that is reliable, compliant, and high quality. This is a top priority for contract manufacturing organizations and their clients today.

Strategic supplier relationships offer a key to success
There’s no question that high-quality cellular starting material is a vital input to the cell and gene therapy manufacturing process. Without it, a contract manufacturer cannot provide a true full service offering or a good client experience.

By establishing contractual strategic supplier arrangements, contract manufacturers can overcome common supply chain challenges, have a reliable source for starting material and deliver a high-quality therapy for their clients and, most importantly, patients. 

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Chris McClain is the Senior Vice President of Sales and Business Development for Be The Match BioTherapies. He leads the sales and business development team, which engages with companies developing innovative, lifesaving therapies that can leverage the cell sourcing, cell therapy supply chain, CRO services, and outcomes tracking capabilities of the NMDP/Be The Match.