Biopharmaceutical drug development: from CMC to clinical PK
An overview of Gyrolab immunoassays and their utility in CMC target binding assays for batch release and stability assessment. Also, for preclinical and clinical PK analysis with a view to transferring assays to a CRO.
This webinar will give an overview of a Gyrolab 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 Gyrolab 2-plex assay can be used to support a program for a therapeutic antibody mixture. The case study will highlight the advantages of speed, data quality and ease of transferring an assay to a CRO.
What will you learn?
- How to maximize the performance and productivity of automated ligand-binding assays
- How automated ligand-binding assays of two monoclonal antibodies can lead to efficient assay development and validation
- How transferring a ligand-binding assay to a CRO can be made easier
Who may this interest?
Scientific Directors and Scientists involved in bioanalytical studies for biologics (monoclonal antibodies, recombinant proteins, etc.).
Symphogen A/S (Ballerup, Denmark)
Rikke has a PhD in molecular antibody technology. She has over 12 years experience in bioassay development, having worked for almost 5 years in a diagnostic company called Bioporto (Hellerup, Denmark) developing diagnostic ELISA kits. Also, for the last 9 years she has been involved with bioassay development, transfer and sample analysis with various platforms including ELISA, MSD and Gyrolab at Symphogen.