Gene Therapy Manufacturing

Optimizing Process Development For Next-Generation Gene Therapies

8/12/2026 - August 13, 2026 ALL TIMES EDT

Cambridge Healthtech Instituteâ€™s 11th Annual Gene Therapy Manufacturing conference explores the end-to-end production challenges of increasing yield and purification of novel and late-stage gene therapies. The agenda covers late-stage manufacturing challenges, process development, scale-up and tech transfer, alongside upstream strategies to optimize cell lines, bioprocess efficiency, automation, and high-throughput optimization. Additional sessions address manufacturability of novel capsids and vectors, process intensification, suspension, scale-up, and downstream innovation in recovery, purification, filtration, chromatography, adventitious agent control, and viral safety.

Preliminary Agenda

Session Block

PLENARY SESSION

PLENARY KEYNOTE PRESENTATION:
The Correct Way to Bring Digital and AI into Biopharmaceutical Quality

Photo of Anthony R. Mire-Sluis, PhD, Senior Vice President, Global Quality, Gilead Sciences , SVP , Global Quality , Gilead Sciences — Anthony R. Mire-Sluis, PhD, Senior Vice President, Global Quality, Gilead Sciences , SVP , Global Quality , Gilead Sciences

Digitalizing quality systems and the advent of artificial intelligence has the potential to revolutionize the way we work in quality. However, it needs careful planning and execution to gain the maximum benefits to the business. Appropriate use cases, change management, training, and streamlining processes before you digitalize is essentialâ€”putting complexity in just results in digital complexity. In addition, the implementation of AI must follow GxP principles in what is currently a vague regulatory framework.

Panel Moderator:

FIRESIDE CHAT: Bringing Digital and AI into Biopharmaceutical Quality and Manufacturing

Photo of Susan Hynes, Global Head of Quality, GSK , SVP, GSK Global Quality , GSK — Susan Hynes, Global Head of Quality, GSK , SVP, GSK Global Quality , GSK

Panelists:

Photo of Lynn Bottone, Senior Vice President, Quality Operations, Environment Health & Safety, Pfizer Inc. , Senior Vice President Quality, Safety & Environmental Operations , Quality Operations, Environment Health & Safety , Pfizer Inc — Lynn Bottone, Senior Vice President, Quality Operations, Environment Health & Safety, Pfizer Inc. , Senior Vice President Quality, Safety & Environmental Operations , Quality Operations, Environment Health & Safety , Pfizer Inc

Session Block

MANUFACTURING NEXT-GENERATION GENE THERAPIES

KEYNOTE PRESENTATION:
Directed Evolution of New AAV Vectors for Clinical Gene Therapy

Photo of David V. Schaffer, PhD, Hubbard Howe Jr. Distinguished Professor, Chemical & Biomolecular Engineering, University of California Berkeley , Hubbard Howe Jr Distinguished Prof , Chemical & Biomolecular Engineering , Univ of California Berkeley — David V. Schaffer, PhD, Hubbard Howe Jr. Distinguished Professor, Chemical & Biomolecular Engineering, University of California Berkeley , Hubbard Howe Jr Distinguished Prof , Chemical & Biomolecular Engineering , Univ of California Berkeley

Adeno-associated virus (AAV) is utilized in numerous FDA-approved gene therapies, though low delivery efficiency limits the success of natural serotypes for the majority of human diseases. For over two decades, we have been implementing directed evolutionâ€”the iterative genetic diversification of the viral genome and functional selection for desired propertiesâ€”to engineer highly optimized, next-generation AAV variants for efficient and targeted delivery to any cell or tissue target. The resulting variants have been effective in both animal models and in numerous human clinical trials to date, and results from both will be discussed.

Advancing AAV Manufacturing with a Nextâ€‘Generation Plasmid Platform

Matt Edwards, VP, Process Science, Affinia Therapeutics , VP, Technical Operations , Process Science , Affinia Therapeutics

This work presents a next-generation plasmid platform engineered to enhance the efficiency, robustness, and scalability of AAV production. By integrating optimized genetic elements with a modular design, the platform increases vector yield and quality while reducing process complexity. This streamlined approach enables more reliable performance across manufacturing scales and offers a transformative solution to meet the growing demand for high-quality AAV therapeutics.

Manufacturing Novel Capsids and Vectorsâ€”Case Study from Apertura

Jorge L Santiago-Ortiz, Senior Director, CMC & Regulatory Affairs, Apertura Gene Therapy , Senior Director , Chemistry & Mfg & Controls & Regulatory Affairs , Apertura Gene Therapy

OPTIMIZING VIRAL VECTOR PROCESS DEVELOPMENT

Innovations in Downstream AAV Purification

Photo of Stephen Soltys, PhD, Chief Manufacturing Officer, Primera Genotech , Chief Manufacturing Officer , Primera Genotech — Stephen Soltys, PhD, Chief Manufacturing Officer, Primera Genotech , Chief Manufacturing Officer , Primera Genotech

Is it possible to level the playing field for process development of AAV Gene Therapies? If we could standardize AAV purification the way that plasmids or even monoclonal biologics are manufactured, we could focus our attention more toward addressing the real problem of AAV gene therapies. In this presentation, optimized purification methods, from lysis to empty full separation, will be discussed.