From platform to GMP: accelerating AAV process development and de-risking GMP manufacturing through small-scale optimization

Wednesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

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From platform to GMP: accelerating AAV process development and de-risking GMP manufacturing through small-scale optimization

Live30 webinars pack the latest innovations and applications into a data-rich 30-minute session.

An established AAV platform can accelerate development, but individual programs, including those using new or modified capsids, may require parameter adjustments to reach target process performance. Small-scale, targeted process optimization provides a practical way to fine-tune platform conditions for a specific product while building process understanding early.

This webinar explores how a platform approach, combined with focused optimization studies, can evaluate selected process parameters at small scale. Generating process and analytical data at this stage shows which platform conditions can be retained, where program-specific changes are needed, and what that means for decisions on scale-up.

Real-world AAV examples will show how small-scale studies evaluated yield, productivity, and product quality, identifying promising conditions and potential manufacturing risks early in development. The discussion will also examine how this understanding can increase confidence in scale-up, reduce the likelihood of carrying suboptimal conditions into later stages, and support faster progression toward larger-scale GMP manufacturing.

Attend this webinar to:

Understand which platform conditions can be retained for a new or modified capsid program, and where program-specific adjustment is needed.
Learn how to design targeted optimization studies that generate process and analytical understanding.
Evaluate real-world AAV data showing how small-scale studies assess yield, productivity, and product quality to support early development decisions.
Apply early process data to identify manufacturing risks and increase confidence in scale-up to GMP.

Cédrick Rousseaux

Innovation, Analytical, and Process Development Director at SK pharmteco

Cédrick Rousseaux has held several positions in Process Development and Technology Transfer since joining SK pharmteco in 2015. Prior to joining the company, he spent more than 15 years in the medical device industry, gaining extensive experience in GMP manufacturing, analytical development, process development, and technology transfer.He holds a Master's degree in Cellular and Molecular Engineering from the University of Lille.

Cédrick is an expert in viral vector process and analytical development specializing in viral vector manufacturing, including lentiviral (LV), adeno-associated viral (AAV), and adenoviral vectors (Ad). Throughout his career, he has successfully led numerous international viral vector development programs, covering process and analytical development, optimization, scale-up, and technology transfer.

He has also played a key role in developing and continuously improving SK pharmteco's proprietary SKyvec platform technologies, contributing to the establishment of robust, scalable, and efficient manufacturing processes for advanced therapies.

Nadia Avenier

Head of Analytical Expertise Center at SK pharmteco

Nadia Avenier is the Head of the Analytical Expertise Center at SK pharmteco Viral Vector Europe, where she leads the development and implementation of analytical strategies supporting gene therapy products from early development through commercial manufacturing. She leads a multidisciplinary team responsible for analytical method development, qualification, validation, technology transfer, and lifecycle management, supporting gene therapy products from early development through commercial manufacturing.

Nadia holds a PhD in Biochemistry and Molecular Biology and joined SK pharmteco in 2019 after more than 10 years of experience in both academia and the contract research organization (CRO) industry. Throughout her career, she has developed extensive expertise in analytical sciences, quality control, CMC development, and regulatory compliance for advanced therapy medicinal products (ATMPs). Her work spans adeno-associated viral (AAV), lentiviral, and adenoviral vector platforms, with a particular focus on analytical characterization, potency assays, identity testing, impurity profiling, and the implementation of innovative analytical technologies.

Nadia is committed to developing platform-based analytical strategies that accelerate product development while ensuring scientific rigor and regulatory compliance. She actively fosters collaboration across research, development, manufacturing, and quality teams and enjoys sharing practical experience and emerging analytical approaches with the broader scientific community.

In 29 Days

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