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Avi Nandi, SK Pharmteco, discusses how on-site media and buffer manufacturing can simplify supply chains and de-risk cell and gene therapy production.
At INTERPHEX 2026, PharmTech connected with Avi Nandi, president of Cell & Gene North America, SK Pharmteco, to discuss the rising needs of media and buffer manufacturing as supply chains continue to have inconsistent stability.
Watch the 2-part video interview with Nandi:
Part 1: Avi Nandi on How CDMOs Are Simplifying Cell & Gene Supply Chains
Part 2: Avi Nandi on the Impacts of On-Site Media and Buffer Manufacturing
Nandi: I look at it in three ways: lead time, consistency, and expiry. As a critical raw material for our manufacturing operations, media and buffers sit at the heart of the supply chain. On the lead time side, most of our clients in cell and gene are operating somewhere between early- and late-stage clinical development. The window from identification to use tends to be short, because clinical supply is the priority. That puts pressure on suppliers to manufacture and ship quickly, and lead time becomes a real constraint.
Once material arrives, we're then working against an expiry clock. For early-stage products especially, the timing of when a material will be used can be unpredictable, so longer shelf life is a meaningful benefit. And then there's lot-to-lot consistency. Many of these buffers and medias are highly specific to a given product, and the understanding of how variances affect the manufacturing process can still be limited. Reproducibility is critical, particularly as product scales through clinical phases and toward commercial launch.
There are strong pros and strong cons. On the positive side, internal control of the supply chain is a huge benefit. You're able to manufacture these materials based on immediate demand, which lowers supply chain risk, reduces cash exposure in raw material procurement, and limits the expiry exposure that comes when manufacturing schedules shift. That kind of agility is genuinely valuable.
The challenge for CDMOs specifically is that our threshold for adoption is higher, because we're supplying a much larger and more diverse client base. We need high-quality, consistent product and any variance in how media or buffer is manufactured could have downstream effects on the manufacturing process that we might not detect until late. So reproducibility and lot-to-lot consistency are non-negotiable for us. That said, I think on-site manufacturing technology is an excellent step forward, and it's ultimately where the industry needs to go to properly support clients.
Because we work with a large and diverse client base, CDMOs have a broader view of demand than an innovator focused solely on their own product. That visibility helps navigate inventory more flexibly and keep reserves where needed, though it's still a risk proposition on our side. For earlier-stage clients, speed is the priority. They need to get into the clinic as fast as possible. Those materials can also be quite product-specific, which makes it harder to absorb inventory risk. As products move toward commercial stage, though, the opportunity grows considerably. You can start building in inventory reserves, redundancy in suppliers, and more robust de-risking strategies. It really comes down to where the client is in their development journey.
Cell and gene is a heavily single-use industry with high consumables, high waste, and relatively new technologies. So, when I think about sustainability, I start with productivity. We're still in early generations of these technologies, and the most impactful lever I can pull is maximizing productivity to reduce the number of manufacturing runs needed. That's different from how chemical industries approach sustainability. For on-site media and buffer manufacture specifically, it comes down to the effectiveness of manufacture and use, avoiding unnecessary resupply runs driven by expiry or inventory management issues. Improve productivity, and you improve sustainability alongside it.