News & Insights
For years, maintaining redundant CDMO partners has been a best practice for pharmaceutical innovators. By diversifying their manufacturing base, pharma companies protect themselves from disruptions caused by unforeseen events, regulatory issues, and manufacturing failures that could halt production of critical medications.
Cell therapy innovators also need this redundancy; however, given that the cell therapy CDMO sector is still in its infancy, developers have arguably relied too frequently on a single partner. While there are numerous reasons that this reliance is imprudent, the following explores five of the top reasons.
1. Regulatory resilience and business continuity
FDA now expects cell therapy manufacturers to proactively manage supply risk, including redundancy planning, to prevent shortages and late-stage surprises. A formal risk management posture isn’t just good practice; it’s increasingly an expectation. Having a second quality CDMO partner in place is a critical element of any good risk mitigation plan.
Recent headlines show why. Atara’s BLA for tabelecleucel was rejected after the FDA raised concerns about a third-party manufacturing site, underscoring how a partner’s inspection issues can impact the timing of approval. Rocket Pharmaceuticals also received a CRL for Kresladi, with FDA inspectors citing manufacturing and CMC issues, as well as the need for further inspections. A vetted alternate site can keep your program moving while the primary resolves observations or scheduling bottlenecks.
2. Capacity, lead times, and slot agility
Cell therapy programs fight chronic capacity and materials constraints and are acutely sensitive to logistics. Aligning work across two CDMOs can offer you slot flexibility, reduce downtime from equipment or supply hiccups, and allow you to surge capacity around pivotal inflection points. A parallel approach can also allow innovators to shorten timelines by running tech transfer, engineering runs, or validation in parallel. Additionally, CDMO partners in distinct regions offer an advantage for products with short shelf lives (e.g., autologous cell therapies) or challenging starting materials (e.g., tumor biopsies).
3. Platform fit and technical breadth
Autologous and allogeneic programs demand different manufacturing philosophies and expertise. While Kincell Bio excels at both, some CDMOs are more skilled in one area than the other. Using a secondary partner ensures that you have access to the full range of expertise and technology platforms needed for your program’s success.
4. Better negotiating position and faster issue resolution
A single-source relationship limits your leverage on pricing, terms, and timelines, while a second partner naturally creates healthy competition. Additionally, and perhaps more importantly, a redundant CDMO provides another partner familiar with your program, adding troubleshooting firepower as challenges arise.
5. Investor value creation and market launch readiness
Boards, partners, and acquirers scrutinize the durability of a cell therapy organization’s supply chain. Demonstrating qualified dual sourcing, complete with cross-validated methods, mirrored critical raw material strategies, and a playbook for rapid scale, signals mature quality risk management consistent with ICH Q9 principles. It’s a tangible way to de-risk late-stage value inflections and defend timelines, both of which increase a cell therapy company’s value.
Kincell Is Ready to Support in Primary or Secondary Partner Roles
Kincell Bio is built to be your reliable primary or secondary supplier. Each day, we run every suite as if a critical inspection could happen tomorrow, with commercial-grade quality systems, disciplined documentation, and inspection-ready operations. Our teams specialize in fast, phase-appropriate tech transfer that protects future validation, comparability, and scale. We standardize where it counts, automate to reduce human variability wherever possible, and bring deep expertise in both autologous scale-out and allogeneic scale-up. Regardless of our position as a primary or secondary supplier, you’re securing resilient capacity without compromising rigor. Contact us if you’d like to discuss your program’s needs.
