Biopharmaceutical drug development:
from CMC to clinical PK
Robust, accurate, precise, and time effective ligand binding assay (LBA) platforms are crucial for the development of advanced bioassays for analyzing therapeutic antibody mixtures due to the inherent complexity of these drugs. LBAs support everything from CMC release and stability programs, to pharmacokinetics preclinical and clinical studies.
In this webinar will provide an overview of a unique flow through LBA system and how it is used to support biopharmaceutical drug development. Uses include bioprocess application and pharmacokinetic assays. A case study from Symphogen will highlight how a 2-plex assay can be used to support a program for a therapeutic antibody mixture. Symphogen has developed a B-cell based platform for cloning from different species and their high throughput platform is used to identify functionalities, including synergistic effects to develop antibodies with unique properties in the field of oncology and immuno-oncology. The company has severalproducts in clinical development, including Sym015, which is in Phase 2a.
The case study will highlight the advantages of speed, data quality and ease of transferring an assay to a CRO.
Attendees will learn how:
to maximize the performance and productivity of automated ligand binding assays
automated ligand binding assays of two monoclonal antibodies can lead to efficient assay development and validation
transferring a ligand binding assay to a CRO can be made easier
Cost: No Cost!
Moderator: John Chappell, BSc CChem CSci FRSC, Gyros Protein Technologies AB
Rikke Hald, M.Sc., Ph.D.,Senior Scientist, Bioassays,Symphogen A/S, Ballerup, Denmark