Antibodies and antibody-based therapeutics have the potential to elicit immune functions through binding to Fc-γ receptors (FcγR) on immune cells or fixing complement. According to ICH Q6B and EMA mAb guidelines, the Fc region of a mAb needs to be characterized for IND and BLA submissions. Working with a passionate, savvy scientific team helps to streamline this part of the process.
Assay Development to Meet Your Needs
For the most common isotypes of therapeutic mAbs, BioOutsource offers pre-developed, pre-qualified assays for analysis of Fc binding to FcγR and C1q. The assays enable faster, more economical characterization of a molecule’s Fc regions with solutions that are ready to implement immediately for early phase testing.
Some of these technologies include:
- FcγR by Biacore (Full Panel)
- FcRn by Biacore (Human, Rat, Mouse, or Cynomologous Monkey)
- C1q by Biacore
- C1q by ELISA
With extensive experience in Fc characterization, our team can work to customize a solution to meet the unique requirements of each product. And with flexible global capacity, including a large facility in Glasgow, UK, services are available where you need them most.
Contact our expert scientists today to discuss how our range of analytical services can improve your unique process.