Cell and Gene Therapy Production and Commercialization Track
Cell and gene therapy (CGT) is entering a new era - one defined by scale, access, and efficiency. At BPI West 2026, the Cell & Gene Therapy Production & Commercialization stream brings together industry pioneers, process engineers, regulators, and technology innovators tackling today’s biggest challenges in CGT manufacturing.
Scaling Advanced Therapies for Real-World Impact - Don't Miss These Key Topics:
Scaling Allogeneic Cell Therapies & Access
The industry is rapidly moving from autologous (patient-specific) cell therapies toward off-the-shelf allogeneic approaches. This shift is vital to improving patient access, reducing cost-of-goods, and enabling wider commercialisation. Find out how engineering strategies for allogeneic CAR-T cells, are increasing scale without compromising quality, supply chain frameworks, and process optimisation. Join sessions such as: “Scaling genome-edited allogeneic CAR-T manufacturing to increase access to cell therapies” which will explore how to bring allogeneic therapies to market efficiently.
Process Development & Commercial Readiness of AAV Gene Therapies
For viral vector-based gene therapies (especially AAV), success hinges on robust process development, meeting regulatory expectations, designing for scalability, and bridging to commercial launch. Talks such as: “From Bench to BLA: Critical Attributes of AAV Vector Manufacturing Process Development” will look at modelling supply needs, COGS, clearance, purity, productivity and regulatory readiness.
Automation, Digitalisation & Efficiency in Cell Therapy Manufacturing
With the complexity and cost of cell and gene therapies high, the push for manufacturing efficiency, automation, process analytics and digital tools is more urgent than ever. Session such as: “Improving Efficiency of Cell Therapy Manufacturing Through Full Automation” will highlight the trend toward integrated, lean, data-driven production platforms for both autologous and allogeneic formats.
Quality Control, Formulation & Supply Chain Robustness
Ensuring product quality, stability, and supply-chain resilience is fundamental as cell and gene therapies move toward scale. Sessions on analytical strategy, formulation, and supply-chain planning for critical materials (e.g., mRNA, vectors) reflect how the industry must tightly control quality attributes, shelf-life, cold chain, and critical raw-material sourcing.
Cell and Gene Therapy Production Speaker Snapshot
FAQs
What topics are covered in the Cell and Gene Therapy Production and Commercialization Track at BPI West?
This track explores end-to-end cell and gene therapy production and commercialization, including viral vector manufacturing, CAR-T and allogeneic therapies, formulation strategies, scale-up challenges, supply chain planning and readiness for commercial manufacturing.
How does the agenda address current challenges in cell and gene therapy production?
The agenda focuses on overcoming scalability, cost, quality and reproducibility challenges that impact the transition from early development into late-stage and commercial production.
Does the track cover both cell therapy and gene therapy manufacturing?
Yes, our content spans both cell and gene therapy modalities, including CAR-T therapies, genome-edited products and viral vector platforms such as AAV, with an emphasis on robust production and commercialization strategies.
What insights are provided on scaling up cell and gene therapy processes?
The agenda examines strategies for scaling production while maintaining product quality, consistency and regulatory alignment, addressing one of the most significant hurdles facing advanced therapy developers.
How does the track address cost reduction and manufacturing efficiency?
Discussions focus on improving production efficiency, reducing cost of goods and optimizing workflows to support sustainable and commercially viable cell and gene therapy products.
Are supply chain and materials planning challenges covered in this track?
Yes, the agenda explores supply chain resilience, contingency planning and access to critical raw materials, highlighting their role in ensuring reliable and uninterrupted cell and gene therapy production.
Does the track include formulation and product quality considerations?
The agenda covers formulation development, stability, cryopreservation and quality-by-design approaches that support product performance, shelf life and regulatory expectations.
How does the content support teams preparing for commercialization of advanced therapies?
The track addresses commercial readiness topics such as process validation, comparability, regulatory expectations and operational planning needed to transition cell and gene therapies toward market launch.
Who should attend the Cell and Gene Therapy Production and Commercialization Track?
This track is designed for process development scientists, manufacturing leaders, engineers, technical operations teams and CMC professionals working across late-stage development and commercialization of cell and gene therapies.