PRESENTATION: Capillary Electrophoresis Methods - Characterization and Quality Assessment of AAVs

PRESENTATION: Capillary Electrophoresis Methods - Characterization and Quality Assessment of AAVs

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DOWNLOAD: https://www.intertek.com/pharmaceutical/characterization-quality-assessment-of-aavs-using-sensitive-capillary-electrophoresis-methods/ Adeno-associated viruses (AAVs) are the leading delivery vehicle for gene therapies due to their safety profile, stability and high efficiency of transduction and high levels of gene expression. To ensure consistency in efficacy and safety, regulatory agencies require extensive definition of critical quality attributes through characterization and impurity analysis of the final product. Various applications and services can be utilised for characterization and quality assessment of AAVs. The main focus of this talk will be presenting a gold standard single platform of capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) using sensitive Laser Induced Fluorescence of two AAV CQAs, identity and purity.
Intertek213Intertek Pharmaceutical Services – Bringing Quality, Safety and Sustainability to Life. Our bespoke, purpose-built GLP / GCP / GMP laboratories have supported developers and manufacturers for over 30 years by providing bioanalytical studies and advanced characterisation programs. We have worked on multiple studies involving cell or gene therapies, mRNA, plasmid DNA based products, and other advanced modalities. Our facility has been designed to handle recombinant genomic materials for the purposes of research and compliant testing, including specialist facilities for handling Class I and Class II Biological Agents. Intertek’s innovative bio/pharmaceutical services are delivered consistently with precision, pace, and passion, enabling you, our customer, to power ahead safely. Our solutions: • Cell and virus characterisation • Virology assays • Host cell and residual plasmid DNA • Cell-based assays / potency testing • General compendial testing • GMP analysis • GCP/GLP bioanalysis • ICH stability storage and testing • Method development and validation • QC release testing • Advanced delivery technology analytical support Find out more: www.intertek.com/pharmaceutical/biopharmaceuticals/gene-therapy-characterisation Contact us today: +44 (0)116 296 1620 | pharma.services@intertek.com Follow us: www.linkedin.com/showcase/intertek-pharma  ATMP Analytical Development Services & CMC Support Presentation Request | AAV Therapies: Developing Effective Analytical Strategies for In-Depth Empty vs Full Capsid Characterization > Brochure | Cell and Gene Therapies Analytical Development Services >

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