Webinar Description:

Viral particle (VP) titer and impurity levels are critical quality attributes in cell and gene therapy (GTC) manufacturing and quality control (QC) and during process optimization.

The regulatory requirements and growing list of complex and time-consuming analytical steps, including limitations in sample volume, that may cause workflow bottlenecks are just some of the challenges that the rapidly growing CGT market is facing.

In this webinar you will hear from three independent speakers how the automated, Gyrolab® immunoassay platform can help break barriers in AAV viral vector analytics, by increasing throughput and productivity, improve analytical capability and data quality, shorten data-driven decisions in process optimization and support transfer to a GMP regulated environment.

Learning Objectives:

• Viral particle titer, HEK 293 host cell protein impurities and other process related impurities are being measured throughout AAV process development and in gene therapy GMP manufacturing and as part of final QC release. Those analytical steps and associated processes are parts of challenges viral vector manufacturers need to address to respond to gene therapy products mandatories qualifications and rapid market growth.
• HEK 293 is the most common cell line used for expression of viral vectors for the development of cell and gene therapies. Thus, measuring HEK 293 HCP impurities from these cells is a critical quality attribute to ensure efficacy and safety of these novel therapies.
• Gyrolab platform can be used next to the manufacturing line and generate data in less than 2h to support “real-time” data/process driven decision.

Speakers:

Maria Gianneli, PhD
Product Manager IAS Consumables
Gyros Protein Technologies

Dr Maria Gianneli joined Gyros in 2019, working initially as a Field Application Specialist, responsible for application support and training of Gyrolab users in Europe. She then moved to the position of Product Manager for Consumables working to ensure we create products that help customers in every step of the biopharmaceutical development process.

Maria has several years of experience in supporting customers globally across multiple scientific fields such as immunoassays, biochemical and cell-based assays, affinity and kinetics characterization.

She holds a MSc in cell mechanics and a PhD in materials science and has worked as a post-doctoral fellow in biosensor and lab on a chip development.

James Norton
MSAT Analytical Development Lead
MeiraGTx

James Norton studied Chemistry at Loughborough university and entered the Biotechnology industry working with Monoclonal Antibodies for use in diagnostic platforms for p24 and HCV. After a short stint in small molecule pharmaceuticals, James joined MeiraGTx as an Analytical Development Scientist. With the growth of Meira, James now heads up the MSAT Analytical Development Team focusing on establishing Gene Therapy analytical methods for translation to the GMP groups as well as looking forward to new emerging technologies and investigational analytics for the Process Development Teams.

Andrea Manterola Juaristi, Ph.D.
QC Lead Scientist in QC Research and Development
Viralgen Vector Core

Dr. Andrea Manterola Juaristi graduated in Biology and received her PhD in Neuroscience in 2019, from the University of the Basque Country where her research focused on the study of cannabinoid receptors and the ABHD6 enzyme as therapeutic targets in demyelinating diseases such as Multiple Sclerosis.

In 2019, she joined Viralgen Vector Core and has focused her professional career in the field of Gene Therapy. As a member of the Quality Control (QC) in Research and Development department, she focuses on the QC analysis of recombinant Adeno-Associated Virus (rAAV) Production. Her department is responsible for performing QC analysis of rAAV products to determine parameters such as viral titer, capsid content, sample purity and vector potency. Her team is also involved in the development and implementation of new methods and systems to improve the performance of the QC analyses conducted on rAAV vectors, as well as for establishing the measurement parameters and acceptance criteria used to validate the analyses.

Cost: No Cost!