Blog | September 8, 2021

CTO Shares Secrets To A Successful Cell & Gene Therapy Supply Chain Strategy

ARW Edit Headshot 2

By Anna Rose Welch, Editorial & Community Director, Advancing RNA


“It’s not exactly rocket science,” Ludek Sojka, CTO, SOTIO, admitted during our conversation on managing raw material supplier relationships to better control overall C&G therapy COGS. However, the past year has proven that securing a reliable supply of raw materials will — despite our best intentions — always be an evergreen challenge. A great reminder of this came in the form of a survey earlier this year revealing that dual-source supply chains — though they are regularly heralded as essential — still remain mythical for 50 percent of advanced therapy survey respondents.

The importance of vigilantly overseeing the supply chain to ensure a high-quality, reproducible, and timely manufacturing process cannot be overstated. While there are many aspects of raw material management to discuss, my conversation with Sojka was a valuable reminder to pay careful attention to building and maintaining operational infrastructure to facilitate flexible and cost-effective supply throughout the ex-vivo manufacturing process. Advances in biology and manufacturing science will only lead to greater efficiency so long as companies do their due diligence in hiring the right talent and promoting cross-team collaboration where it matters most.

Don’t Underestimate The Importance Of Supply Chain Talent

There are several factors that can impact a company’s ability to establish and maintain strong relationships with suppliers. These include the age and experience of the overall company, the stage of product development (e.g., moving from research-grade to GMP materials) and the type of product, and the rate of turnover within its supplier management team. To Sojka, talent is a critical component companies should not overlook when establishing their supply chain operations.

Most of the recruitment/hiring energy today is seemingly directed towards those with cell culture, process development, C&G manufacturing, and/or viral vector experience (among 1,000s of other things — and for good reason). However, Sojka emphasized how important it is to have the right person/people in-house experienced in forming new and expanding existing supplier relationships. Project management skills are essential here. “You need someone who can reliably organize tasks, maintain a rigid schedule, and communicate properly with the suppliers,” he explained.  

Fostering long-term employees in these roles can also be an organizational benefit. As Sojka shared, SOTIO has been lucky to have limited turnover in these supply chain management roles, which helps simplify building out a pipeline and garnering critical raw materials for new development programs. The longer the tenure of the company and its supply chain team, the more likely the company is to have a network of reliable, qualified suppliers to turn to for new projects.       

Forecasting Your GMP-Raw Material Needs: Who Must Be At The Table 

For many companies starting out, the draw is toward the science, which typically means sourcing cheaper, research-grade materials for small-scale, preclinical development. Securing more costly GMP-grade materials becomes a priority upon approaching clinical and commercial development. (However, it’s worth noting that some have begun to advocate for turning away from the phase-appropriate approach and sourcing GMP-grade raw materials earlier as the regulatory pathway and quality expectations grow increasingly clear.)  

There have been thousands of articles written on the nuances of contracting and partnering to guarantee reliable and transparent supply of GMP-grade materials. However, my conversation with Sojka gravitated towards another factor that’s just as important and challenging for autologous companies to tackle — accurately forecasting patient recruitment and manufacturing capacity to secure the necessary supply of GMP-quality materials. An autologous therapy company must be able to answer this central question: Do we have enough capacity to manufacture this treatment?  

“The answer should be yes,” Sojka said (and laughed). “If it’s no, then you must either partner swiftly with a CMO or pivot your strategy/product development. We recently asked ourselves this same question in order to book sufficient manufacturing capacities next year for SOTIO’s BOXR1030 CAR-T program.” 

When I asked who should be in the room for such forecasting discussions, he emphasized first and foremost that there must be regular interaction/meetings between the heads of tech ops/manufacturing and clinical operations. Such collaboration allows companies to build their clinical and manufacturing plans in parallel — and, in turn, to more accurately predict the supply of critical raw materials. As Sojka outlined, regular (i.e., monthly) meetings keep both teams apprised of any approaching capacity constraints or recruitment challenges.  

For example, patient screening failures can throw off even the best-laid plans for a particular month’s recruitment. In light of this, the company’s clinical and manufacturing teams will need to plan to make up for that patient enrollment at a later date without overestimating available capacity. These discussions will also facilitate accurate calculations for the minimum amount of GMP-grade material supply. After all, Sojka pointed out, if you are unable to meet those minimums stipulated in your supplier contracts, you will not be able to obtain the GMP materials and your manufacturing timeline will be pushed back.  

In addition to obtaining the appropriate amount of raw material supply, precise forecasting also keeps the all-important COGS for these expensive therapies top of mind.  

“It has always been better for us cost-wise to be open in our discussions with suppliers around our expected batch numbers per year,” Sojka explained. “These numbers must align with your rolling forecast for the number of patients you’ll recruit for your clinical studies and the number of products you’ll ultimately be manufacturing over the course of two to three years.” This, of course, is supplier-dependent, Sojka admitted; such an arrangement may only be possible when working with smaller suppliers, which can require heavier lifting/more handholding on the quality side. 

Sojka was clear that collaboration between clinical and manufacturing teams is likely (and should be) a well-established process for seasoned biotechs. But as we are in a nascent space with many new and inexperienced companies, hiring the right talent and uniting the manufacturing and clinical teams are fundamental challenges C&G companies will face as they progress towards clinical and, hopefully, commercial development.  

“A reliable company is defined by a management team that regularly requests information around the anticipated patient recruitment, available capacity, and any challenges that are or could be encountered in obtaining your critical raw materials,” he concluded. “The more precisely you can forecast, the more precisely you can plan your budget without encountering any unpleasant surprises in-house and with your investors.”