Abzena, FDA Partner on Benefits of MAPPs Assay for Immunogenicity

Abzena, a contract development and manufacturing organization (CDMO) for complex biologics and bioconjugates, has co-authored a publication with the U.S. FDA demonstrating the potential of the MHC associated peptide proteomics (MAPPs) assay as an important method to interrogate immunogenicity risk and help design superior antibodies and biologics with a higher chance of a successful outcome in patients.

The authors highlighted the value of MAPPs in the development of biologics and the precision it offers in identifying potential immunogenicity risk, a factor that can lead to suboptimal drugs or termination of clinical programs if anti-drug antibodies (ADAs) are induced in patients. Adoption of MAPPs within the biotech industry as a tool in immunogenicity testing could help reduce this risk and streamline biologics development.

In a statement, Abzena said that it has over 20 years of experience in developing phase-appropriate assays for the assessment of potency, efficacy, and safety. Demonstrated to be an effective tool in de-risking biologics in early preclinical stages and offering significant benefits over traditional immunogenicity assays, Abzena has integrated the MAPPs assay into its extensive immunogenicity service offering.

Campbell Bunce, chief scientific officer at Abzena, said, “We are proud to collaborate with the FDA on this journal article highlighting the advantages of utilizing MAPPs as a tool in immunogenicity assessment. This is a highly precise, and despite its complexity, robust assay, that provides information about processing and presentation by immune cells that can inform regions of drugs that may promote the induction of ADAs.”

Bunce added: “Both pharma and biotech customers stand to benefit from methods such as MAPPs in conjunction with in silico assessments and T cell proliferation assays to de-risk their drug development programs. By utilizing MAPPs, we can support our customers in delivering safer, more effective therapies to patients faster.”