The development and manufacture of therapeutic antibodies represents an important part of the biopharmaceutical industry and has brought huge benefits to public health. Therapeutic antibodies rely on two types of functions to achieve clinical efficacy: (i) target-specific binding through variable domains, and (ii) the immune-mediated effector function through the interaction of Fc (crystallizable fragment) domains with cell receptors and complement proteins. Antibodies and antibody-based therapeutics have the potential to stimulate immune function by binding to Fc-γ receptors (FcγR) on immune cells or fixing complement.
According to the ICH Q6B and EMA mAb guidelines, for IND and BLA submissions, the Fc region of the mAb must be characterized. Focusing on the development of antibody therapies for many years, Creative Biolabs provides a diversified portfolio of Fc function characterization services to support the development of biobetter or biosimilar therapies. In particular, we provide cell-based functional assays for evaluating antibody effector functions and/or Fc engineering services for antibody function regulation.
The Fc region is the tail of the antibody, which interacts with cell surface receptors called Fc receptors and certain proteins of the complement system to trigger complex downstream signaling events and activate the immune system. In this way, Fc can mediate different physiological effects of antibodies, including detection of opsonized particles, cell lysis and leukocyte degranulation. For therapeutic antibodies, the Fc region can play an important role in its safety and efficacy. Therefore, in the process of antibody development and production, Fc function should be carefully studied and controlled.
For the most common isotypes of therapeutic mAbs, Creative Biolabs provides pre-developed, pre-validated assays for analyzing the binding of Fc to FcγR and C1q. This assay can be implemented immediately for early testing, allowing faster and more economical characterization of the Fc region of the molecule.
Some of these services include:
With extensive experience in Fc characterization, our team can work on custom solutions to meet the unique requirements of each product. With flexible global capabilities, you can provide services where you need it most.
Contact our expert scientists today to discuss how our range of Fc analytical services can improve your unique process.
Creative Biolabs provides luciferase-based ADCC assay. This Jurkat cell based assay is pioneered by Creative Biolabs, and the methodology is very well accepted by the field. See attached ADCC Reporter Assay Protocol for further details.
All products and services are for Research Use Only. Do Not use in humans.
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Creative Biolabs has established a team of customer support scientists ready to discuss ADCC/CDC optimization strategies, antibody production, bioinformatics analysis and other molecular biology/biotechnology issues.