Immunogenicity Assays For AAV Gene Therapies

Capabilities

Recorded: November 2022

This webinar will discuss immunogenicity assays as an integral part of large molecule bioanalysis. Presentations will focus on the practical aspects of developing and validating tests to assess both humoral and cellular immunogenicity. Based on our experience and case studies, we will discuss both the advantages and challenges bioanalytical labs face while working on such studies.

Register to watch our webinar on-demand

You can ask your own questions of our experts.

Name(Required)

First Last

Company Name(Required)

Job Title(Required)

Country(Required)

State

Email(Required)

Thank you for registering to watch our on-demand webinar. By submitting this form, you consent to the collection and processing of your personal data by Pharmaron in accordance with our Privacy Policy. You may be contacted by email following your webinar viewing regarding any questions you may have, as well as relevant services and updates. You can unsubscribe or withdraw your consent at any time.

Agenda

Challenges with immunogenicity assessments as it pertains to AAV Gene Therapies
- Regulatory guidance and industry practices related to these products
- Steps of the development, from early preclinical assessment to the qualified clinical assays
- Pre-existing immunity and impact on the assay development
- Identification of appropriate controls for the clinically meaningful assay
Humoral Immunogenicity testing
- A multitiered approach to immunogenicity ADA testing
- Assay Validation parameters
- Developing the right cutpoint is a critical step in ADA assays
Role of cell-based assays in evaluating immune response: ELISpot and Nab Assays
- Advantages and challenges of ELISpot technology
- Case study: Validation of Nab assay for CGT
- Statistical analysis of the data

Meet our Speakers

Speakers:

Key Opinion Leader: Zoya Gluzman-Poltorak PhD, VP of Therapeutic Development, ASC Therapeutics

Dr. Gluzman-Poltorak has over 20 years of executive-level leadership experience in early development biotechnology companies, advancing several gene, cell, and protein-based products from ideas through pre-clinical into clinical development in multiple therapeutic areas. In 2017, Dr. Gluzman-Poltorak pioneered the ASC Therapeutics Division to lead the cutting-edge AAV-based genome editing, gene, and cell therapy products. Under her leadership, ASCTx completed the IND-enabling pre-clinical and analytical program for ASC618, an AAV-based Gene Therapy Hemophilia A program, in less than 1 year.

Dr. Gluzman-Poltorak received her PhD in Cell Biology and Genetic Engineering and MBA from the Technion, Haifa, Israel.

Pharmaron Speakers:

Kate Patterson, Associate Director BioAnalytical

Kate is the Associate Director of the Bioanalytical group at the Boston site of Pharmaron. Ms. Patterson holds a B.Sc. in Animal Science from UMASS, Amherst, and has worked at Pharmaron for 13+ years. She has extensive experience in developing and validating e immunoassays like ELISA, Western Blot, ADA, Enzyme activity tests, Luminex, etc, and served as a PI on multiple GLP, GCP, and GMP projects.

Babette Haven, Associate Director BioAssay

Babette is an experienced scientist and a leader of the Bioassay group. She is responsible for different cell-based assays, including Flow Cytometry, ELISpot, Nab, compound screening, etc. Ms. Haven was previously employed at Santa Cruz Biotechnology and received her B.A. in Chemistry from the University of California, Santa Barbara.

Opportunities and Challenges of Immunogenicity Assays for AAV Gene Therapies