By Anna Rose Welch, Director, Cell & Gene Collaborative
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In recent months, I watched an Endpoints News webinar entitled, “Strategies For Building A Cell Therapy Manufacturing Facility.” The webinar, which included executives from Tenaya Therapeutics, Iovance, Kite Pharma, and Instil Bio, provided some great considerations and best practices for those of you who have chosen to take the plunge into building your own capacity.
Because the C&G space is a wild adventure, to say the least, I wanted to share these experts’ insights in a less traditional way: via a (very simple) “choose your own adventure” series of articles. This “adventure” addresses the following scenario:
As you were completing your walk through the park with Alexis Melendez, senior director, facilities and engineering, Kite Pharma, you noticed that a man at a nearby ice cream truck had started waving at you both in familiarity. It turns out that this man, Faraz Siddiqui, is yet another manufacturing compatriot; he is the VP, process development & manufacturing operations for Instil Bio.
Alexis ushers you over towards Faraz, explaining that he not only has fabulous taste in ice cream (Blue Moon=the best), but he also has experience establishing a cell therapy facility and would be more than happy to address any additional questions you may have. After introducing yourself and ordering yourself some ice cream (#priorities), you sit down at a nearby café table with Faraz and Alexis to discuss how you can best approach capacity planning and know if and when it’s the right time to expand your future facility.
It goes without saying that a cell therapy manufacturer must know that it has enough capacity to handle patient demand — especially since your treatment is often the patients’ last hope. But on the opposite side of the spectrum, no one wants to find themselves in the (costly and potentially bottom-line-damaging) situation where there is capacity left sitting fallow.
Overbuilding is not a unique threat to cell therapy manufacturing — it’s been a foe to many a biologics manufacturer. But this is why Faraz emphasized the importance of phased implementation, because it enables a company to prioritize and put its money first towards R&D and CMC development work instead of constructing infrastructure that might not be needed for some time.
“We first had to make sure that we had acquired enough space upfront and had the right-size utilities,” he outlines. “As you know, building capacity is not cheap. So, to successfully do a phased build, you need to make sure you ask yourself early how much space overall will be needed to make your therapy so that you can plan ahead.”
In addition to evaluating your capacity needs and their associated costs, Faraz implores you to remain devoted to continuously improving the manufacturing process. These learnings will not only impact your facility design, but also facility operations. “The question you want to always be asking yourself is, ‘How do we gain this efficiency within our facility(ies)?’” Faraz advises. To do justice to this question, it behooves you to not build capacity too far in advance.
You must also have a more “global” understanding of scale-up that extends beyond your manufacturing process. As the company advances, manufacturing scale will not be the only operation that is increasing; there are a handful of supporting areas that will require additional love and attention so that they, too, can be scaled-up in parallel to adequately support manufacturing. Two particular areas worthy of your attention, Faraz points out, include your quality control operations and the collection of starting materials from the clinics. The latter operation is particularly critical seeing as it is not going to be part of your central facility.
At this point, you note with immense disappointment that you’ve just finished your ice cream cone. To distract yourself from going and getting another one (effectively resigning yourself to an extra 30 minutes on the treadmill later), you quickly ask Faraz to share his thoughts on how you can know it’s the right time to move beyond the first phase of your build and expand beyond your initial capacity allotment.
It’s really a confluence of three factors, he starts out. Obviously, one is the state of your pipeline development — in other words, how widely your process differs or will differ across the products in your pipeline.
Secondly, it will depend on the state of your manufacturing platform as a whole. “You have to know at what point you will be ready to incorporate some of that innovation into your facility design,” he says. “If your platform isn’t done yet, you would be ill-advised to trigger that expansion because you’re ultimately delaying the benefits that will come from that platform.”
Finally, it comes full circle back to the patients. If your clinical data is solid and indicating that it’s time to expand — regardless of whether your technology or operations are where they need to be — you ultimately have to make the patient-centric decision.
As Faraz concludes his thought and stands up to throw out his napkin, you notice a group of your coworkers walking out of your office across the street to go take a much-needed afternoon coffee break.
Now you have a choice: you can leave Alexis and Faraz and join your coworkers for coffee to share the details of your recent interactions.
Or, as you watch your cohort head into a nearby Starbucks, you realize that successfully scaling your manufacturing operations will also require a significant amount of talent management. Your organization — regardless of your technological and manufacturing prowess — will only be as efficient as its teams and established procedures. You turn back to Faraz and Alexis and invite them to coffee to share their thoughts on establishing a proper workstream within a quickly growing company.