Bioanalysis Zone

Biopharmaceutical drug development: from CMC to clinical PK

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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.).

Speaker:

Rikke Hald, MSc, PhD
Senior Scientist, Bioassays
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.

 

In association with:

Gyros Protein Technologies

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