With the rapid development of many pharmaceutical products, biosimilars (or biotherapeutics) are also prosperous in the bio-manufacturing industry. Biotherapeutics are widely used for their good histocompatibility and cell affinity. However, such externally introduced biological agents are still inevitably recognized and phagocytized by the immune system, causing serious adverse reactions or side effects. Therefore, studies on the immunogenicity of biological agents are very important and can effectively avoid the activation of immune cells in the body. Almost all biopharmaceutical products can cause certain anti-drug antibody (ADAs) reactions, which may reduce the efficacy of the drug or cause serious adverse reactions. Creative Biolabs owns a variety of testing methods and techniques to provide you with the most accurate data results in ADA evaluation.
For biopharmaceutical drug analysis, it is not an easy task to establish general methods to fit all drug evaluation and regulatory demands. It requires a lot of repeated “honing” of theoretical and practical experience. For some drugs with long half-life or drugs that require repeated administration, ADA is easy to form multiple immune complexes with the drug to be tested, which is not conducive to the detection of ADA. For example, multiple doses may interfere with the detection of ADA and drug targets or may be difficult to quantify by ADA interference pharmacokinetic (PK) studies and/or toxicokinetic (TK) studies, not conducive to preclinical studies.
Fig.1 Free and partially bound PK assays. (Kelley, 2013)
Regarding how to determine the presence of ADA in the sample, we can follow the steps:
The combination of ADA and PK detection methods brings new hopes and opportunities for the immunogenicity detection of preclinical biotherapeutics. Creative Biolabs can offer various detection methods and emerging technologies. If you are interested in immunogenicity testing, please contact us in time about more details and we will be glad to serve you.
Reference
All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.