From IND to Commercial Reality: Scaling Cell and Gene Therapy Manufacturing

Join Us for This Live Webinar
Tuesday, September 25, 2026 – 1:00 PM ET

Commercializing a cell and gene therapy requires more than scaling a process. It requires the deliberate evolution of a CMC strategy — one that matures from early‑phase agility to commercial robustness, regulatory sustainability, and lifecycle management. In this webinar, we will discuss what sponsors should look for in a commercialization partner and how true collaboration beyond the contract enables successful transition from early development to commercial supply. We will examine how CMC expectations shift from IND‑enabling through BLA and into commercial launch, and why designing with the end in mind is critical to long‑term success.

We will highlight how value stream mapping during late phase scale up can uncover hidden inefficiencies across vector strategy, manufacturing operations, and supply chain, driving significant batch cost reductions while maintaining quality and regulatory compliance. We will also address when it makes sense to challenge conventional industry approaches, how process optimizations may intersect with regulatory expectations, and why change, even post approval, can be both necessary and manageable. Importantly, we will discuss how to approach post‑approval change as part of a proactive lifecycle strategy rather than a reactive necessity.

Finally, we will outline key manufacturing and operational considerations at each stage including early phase, IND enabling, BLA, and commercial ramp up, and share practical lessons to help teams design today with tomorrow’s commercialization in mind.

Key Takeaways: 

• Understand how CMC strategy must evolve from clinical development to commercial manufacturing, and how selecting the right partner supports that evolution
• Identify how value stream mapping and integrated vector and manufacturing strategies can reduce batch cost, improve efficiency, and support regulatory compliance
• Recognize critical manufacturing and operational inflection points  across early phase, IND enabling, BLA, and commercial ramp up to proactively design for long term success

---

Speaker Details:

Bio: Dr. Luciana Mansolelli serves as our Chief Quality Officer at Minaris, bringing over 29 years of global leadership in quality, development, and manufacturing for advanced therapies including biologics, medical devices, and cutting-edge cell and gene therapies. She has a proven track record of building robust quality systems, driving operational excellence, and guiding teams through complex regulatory landscapes and has extensive experience working with global health authorities and non-government bodies on drug development, manufacturing and commercial compliance, and legal frameworks across multiple GxP disciplines and products. Luciana leads our global quality strategy, ensuring the highest standards are met across all programs and sites.

Bio: Dr. Eytan Abraham serves as Chief Commercial and Technology Officer at Minaris Advanced Therapies, bringing over 20 years of experience in cell and gene therapy and biomanufacturing. He combines deep scientific expertise with proven leadership across commercial strategy, process and analytical development and innovation. In his dual role, Dr. Abraham oversees global commercial activities and leads technology and innovation initiatives to help clients accelerate development, scale manufacturing and deliver advanced therapies to more patients.

Before joining Minaris, Dr. Abraham held senior roles at National Resilience, Lonza and Pluristem Therapeutics, leading R&D, commercialization and strategic growth in advanced modalities.

Dr. Abraham earned his Ph.D. in Neuroendocrinology and Developmental Biology from the University of Maryland Biotechnology Institute and completed postdoctoral training in cell therapy and tissue engineering at the Harvard-MIT Biomedical Engineering Center and Harvard Medical School.