Ajinomoto Bio-Pharma Services Introduces Bioconjugation Technology for ADC Manufacturing

Ajinomoto Bio-Pharma Services recently presented data at the World ADC Summit in San Diego this month describing a proprietary site-selective bioconjugation technology, AJICAP. The AJICAP technology allows developers of therapeutic Antibody Drug Conjugates (ADCs) to better control both the location of payload conjugation to an antibody along with fine tuning the quantity of payload attached. Conventional ADCs, which are currently commercially available, are produced as heterogeneous mixtures containing a stochastic distribution of payloads decorating the antibody molecules. The controlling of the Drug-to-Antibody Ratio (DAR) in the development of next-generation ADCs is believed to assist in increasing the therapeutic window of these targeted biologics, leading to overall better clinical efficacy and less toxicity.

The AJICAP technology was developed within Ajinomoto’s Research and Development organization in Kawasaki, Japan. Aji Bio-Pharma presented data obtained via internal research as well as partnerships with biopharmaceutical companies. The data presented shows that deployment of the AJICAP technology in preparation of ADCs demonstrated enhancement of the therapeutic window by achieving a site-specific DAR of 2 with native antibodies when compared to stochastic ADCs, which contain a mixture of DAR species. The data also showed a wide drug-linker compatibility and reactive group compatibility including thiol and azide functionalities. In addition, the Ajinomoto Bio-Pharma team demonstrated that the technology could be scaled to produce gram quantities of ADCs for preclinical testing.

“The AJICAP technology utilizes a proprietary affinity peptide to direct controlled conjugation to the antibody in a relatively straight-forward synthetic process. This is technology that can easily be transferred to the manufacturing floor since it shows high productivity and short conjugation reaction times, which all lead to an ease of manufacture. We have demonstrated with model ADCs and utilizing client-provided materials that the technology is effective and scalable,” said Brian Mendelsohn, PhD, Director of ADC Process Development and Tech Transfer at Aji Bio-Pharma.

Aji Bio-Pharma provides ADC process development, analytical, drug substance and drug product manufacturing services from its recently constructed facility in San Diego, CA.

Jason Brady, PhD, Sr. Director Business Development, added “This is the next step in Ajinomoto Bio-Pharma’s service offering to our clients. The AJICAP platform developed by our Ajinomoto colleagues in Japan provides our clients access to site-specific conjugation technology that can be coupled with our process development and manufacturing services in San Diego, CA. We look forward to introducing the technology to our client base interested in ADCs and other products requiring bioconjugation.”

Tatsuya Okuzumi, PhD, Associate General Manager of R&D Planning at Ajinomoto also added “The demonstration of feasibility of the first generation AJICAP technology has been successful. We are now working to improve the platform in order to broaden the scope of capabilities including additional conjugation sites on the antibody. We look forward to presenting updates at future meetings.”

 Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including: Corynex® protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client’s needs. For more information, visit www.AjiBio-Pharma.com.