During monoclonal antibody manufacturing, process-related impurities such as host cell proteins and protein A can affect product safety, activity, quality and stability. Downstream purification processes aim to remove these impurities, and residual levels must be minimized in the final product. Using a case study, this webinar will introduce a novel automated immunoassay-based alternative using nanoliter-scale microfluidics in place of ELISA, which is considered the gold standard method for impurity quantification.
In this case study, the platform was used to quantify residual host cell proteins, measure and titrate the antibody and verify that the antibody binds specifically to its target (target binding assay) in bioprocess samples. The study demonstrates how the new technology can streamline clinical batch release testing as a reliable alternative to conventional ELISA.
Register for this webinar to learn how automated immunoassay solutions can streamline impurity quantification and clinical batch release.
Speakers
Fabrice Cantais, Senior Scientist, Analytical Leader for Biologics, Servier
Fabrice Cantais currently holds the position of Analytical Leader for Biologics at Servier and is a Biochemical Engineer with extensive experience in analytics, particularly in protein mass spectrometry characterization and monoclonal antibody analysis. Before joining Servier, Fabrice spent 10 years as a Scientist at Quality-Assistance, a CRO based in Belgium, where Fabrice was responsible for physicochemical analysis of monoclonal antibodies, including method development and validation, various studies, quality control and stability assessments for numerous clients, with a primary focus on characterization by high-resolution mass spectrometry.
Read more...
Fabrice was directly involved in the decision to implement the automated Gyrolab® immunoassay platform in the laboratory.
Read Less...
Kira Hedström, Application Scientist, Gyros Protein Technologies
Kira Hedström is an Application Scientist with the R&D team at Gyros Protein Technologies, specializing in cell and gene therapy applications. She has worked on assay projects for various gene therapy vectors, including AAV and exosomes. Kira has an MSc in Synthetic Biology and Biotechnology from the University of Edinburgh, with expertise in Regenerative Medicine and Genetic Engineering. She has spent three years as a consultant at various immunoassay companies, including Thermo Fischer, Cytiva and Biovica, and has a broad insight into the assay development process.
Message PresenterWho Should Attend?
This webinar will be relevant to professionals working in the following fields within the biotech, bioprocessing, pharmaceutical and biologics contract development and manufacturing (CDMOs) industries:
- Downstream Processing
- CMC
- Process Development
- MSAT
- Quality Control
What You Will Learn
Attendees will:
- Learn about an alternative automated immunoassay technology and how it performs compared to traditional ELISA
- Discover how the features of an automated immunoassay technology have enabled a biopharma to improve immunoassay method performance
- Explore case studies demonstrating the implementation of an automated immunoassay technology for quantifying IgG titer and residual impurities, as well as for evaluating product potency with target binding assays at a biopharma
Xtalks Partner
Gyros Protein Technologies
Gyros Protein Technologies provides enabling bioanalytical and peptide synthesis solutions that help scientists increase biomolecule performance and productivity in research, drug discovery, pre-clinical and clinical development, and bioprocess applications. Proprietary high performance nanoliter-scale immunoassay platforms, Gyrolab® xPand, Gyrolab® xP workstation and Gyrolab xPlore™, are used by scientists in leading pharmaceutical, biotech, CRO, and CMO companies for bioanalytical applications such as pharmacokinetics/pharmacodynamics, immunogenicity, and quantitating bioprocess-related impurities. Our low to mid-scale peptide synthesizer platforms and chemistries deliver uncompromising purity, flexibility, and quality for discovery and pre-clinical studies of simple to complex multifunctional peptides. Our peptide synthesis and bioanalytical solutions accelerate your discovery, development, and manufacturing of safer biotherapeutics. Gyros Protein Technologies is part of the Biopharmaceutical Division of Mesa Laboratories, Inc.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account