In adeno-associated viral (AAV) and lentiviral (LV) vector process development and manufacturing, the need for accurate and efficient titer measurement as well as process impurity (eg. host cell protein, endonuclease) and process contaminant (eg. resin ligands) analysis is high. Automated immunoassay platforms provide process development and manufacturing professionals with a powerful tool to accelerate these analyses.
In this webinar, a panel will discuss several case studies that describe how an automated immunoassay platform can accelerate titer and impurity and contaminant analysis in both AAV ad LV vector process development and manufacturing workflows.
Specifically, the panel will discuss parameters to consider when deciding which immunoassay platform to use for analytical testing in process development and manufacturing, share best practices for transferring and validating manual ELISA assays to automated platforms. They will also discuss considerations for adapting commercially available kits, intended for manual immunoassays, to an automated immunoassay platform.
Attend this webinar for insights into:
- What to consider when deciding which immunoassay platform to use for analytical testing of AAV and LV vectors
- How to accelerate and automate manual ligand binding immunoassays (ELISA) to increase workflow productivity
- Analytical assay development approaches used to transfer kits designed for manual immunoassays to an automated platform
John Chappell
Senior Global Scientific Support at Gyros Protein Technologies
John Chappell has approximately 25 years of experience in the Contract Research industry supporting both preclinical and clinical drug development. He has specialized in supporting biological compounds from an analytical perspective e.g. Pharmacokinetic, Immunogenicity and Biomarker analysis. He is particularly interested in validation requirements and ensuring that data generated will be acceptable to the regulatory authorities.
He has spoken at many international conferences on various topics including Oligonucleotide analysis, Biomarker Analysis, Immunogenicity and the analytical support of Biosimilar programs. He now leads the Application Support and Service teams for Gyros where he is responsible for customer service and technical support in Europe and the Asia Pacific regions. John has been a user of the Gyros system for over 10 years so will use this experience to help customers.
He is a Fellow of the Royal Society of Chemistry and was involved in the American Association of Pharmaceutical Scientists (AAPS) Biosimilar Committee that has prepared papers on Pharmacokinetic and anti-drug antibody assays.
James Norton
Director of Analytical Development at Meira GTx
James Norton, works at MeiraGTx as Director of Analytical Development. James joined MeiraGTx in 2018 and has held different roles including Head of Quality Control. Prior to joining MeiraGTx James worked in a variety of roles within the pharmaceutical industry and has gained extensive experience in GMP/GLP quality release and stability testing, as well as analytical method development and validation across Biotech, Small molecule and ATMP’s.
In his current role as Director of Analytical Development at MeiraGTx James leads the R&D department providing analytical services for AAV gene therapy in ophthalmology, salivary gland, and neurodegenerative diseases.
Iñaki Osorio Querejeta
QC Biochemistry Lead at Viralgen
Iñaki Osorio Querejeta, PhD Neuroscience has a position as QC Biochemistry Lead at Viralgen, San Sebastian, Spain.
Iñaki holds an MSc degree in Neuroscience from the University of Cantabria, and a PhD in Neuroscience, from the University of the Basque Country.Iñaki joined Viralgen, a CDMO company specialized in the production of rAAV viral vectors, in early 2020 as Scientist. In his current role as QC Biochemistry Lead in the Quality Control Department, Iñaki has gained experience in managing a GMP Lab, performing task such as documentation writing and approval, TT and validation management, Audit inspections and Quality Management System. Additionally, he has work in the use of different technologies for protein identity, vector purity, capsid titration, and impurity and process contaminants for both validation processes and routine assays.
Barbara Rodriguez
Analytical Development Scientist at VIVEbioTech
Barbara Rodriguez holds a MSc in Applied Chemistry and Polymers from the University of the Basque Country, and Doctor in Biomedical Biotechnology from the University of Barcelona.
She began her research activity in the field of nanobiotechnology followed by specializing in the development of immunoassays based on the detection of biomarkers related to infectious diseases.
Bárbara joined VIVEbiotech, a CDMO specialized in the manufacturing of lentiviral vectors, in early 2022 and holds a position as Analytical Development Scientist in the Quality Control Department.
