AAV production and purification: key steps from design to GMP readiness

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

AAV production and purification: key steps from design to GMP readiness

The imperative to streamline AAV process development and reduce costs continues to dominate the gene therapy manufacturing strategic agenda. In this webinar, the Heads of Upstream and Downstream Processing at Siegfried DINAMIQs will demonstrate how to efficiently develop and implement an AAV production scale-up process in just 4-6 months.

Through a case study, the speakers will share detailed insights into the design, optimization, process development, and characterization required for rapid and robust AAV manufacturing scale-up. They will demonstrate how the evaluation of key materials including cell lines, plasmids, media, and transfection reagents facilitated a seamless transition to 50 L GMP production-scale for a therapeutically relevant gene of interest.

Finally, the presenters will review the pathway they took to defining a quality target product profile (QTPP) for AAV purification and analysis, exploring such key aspects as selection and performance of the initial capture chromatography unit operation, empty/partially full/full capsids separation, viral titer, infectivity, genome heterogeneity, and impurity quantification.

Attend this webinar to:

Receive a blueprint for developing and implementing a scale-up AAV process to quickly transition from RUO benchtop to GMP 50 L production scale.
Understand the impact of key raw material selection on the critical process parameters for therapeutically relevant genomes of interest, and on AAV production scale-up
Review data on the purification process, including separation of closely related AAV species (empty/partially full/full capsids)
Learn novel, optimized techniques for producing, purifying, and analyzing AAV vectors for gene therapies

Goutham Ganjam

Head of Upstream Process Development at DINAMIQs

Goutham Kumar Ganjam is a seasoned expert in AAV gene therapy manufacturing, with deep expertise in gene of interest (GOI) cassette optimization and upstream process (USP) development up to 50-liter pilot scale. At DINAMIQS and previously at DINAQOR, he led the development of scalable AAV production platforms tailored for cardiac, muscle, and central nervous system (CNS) indications. His work integrates vector design, plasmid engineering, and high-yield transient transfection systems to maximize vector potency and expression. Goutham has successfully translated preclinical AAV production workflows into robust USP processes, including suspension culture optimization and process intensification strategies. At DINAQOR, he played a key role in establishing AAV manufacturing capabilities aligned with disease-specific tropisms and tissue targeting. Currently, as Head of Upstream Process Development at DINAMIQS, he oversees vector manufacturing from GOI cassette design to 50L bioreactor scale, with a focus on quality, scalability, and GMP readiness. His cross-functional experience bridges academic insight and industrial execution, driving innovation in gene therapy development. Goutham holds a Ph.D. in Biochemistry from the University of Göttingen and has authored over 20 publications in molecular medicine and vectorology.

Florian Leseigneur

Head of Downstream Process Development at DINAMIQs

Dr Florian Leseigneur is a clinical pharmacologist with experience in process development, analytical characterization, and quality control of broad range of sterile pharmaceutical products. Florian has served as a process development and viral vector senior scientist at several European companies including Cell & Gene Therapy Catapult and Celonic Group. He is specialized in the downstream processing of gene therapy products including lentiviral and AAV vectors.

in 29

Days