Ajinomoto Bio-Pharma Services has launched a bioconjugation technology it says has high productivity and short conjugation reaction times.
According to contract development and manufacturing organization (CDMO) Aji Bio-Pharma, its AJICAP technology lets antibody-drug conjugates (ADC) developers better control the location of payload conjugation to an antibody and fine tune the quantity of payload attached.
“The technology deploys a proprietary affinity peptide to direct controlled conjugation to a specific sites on the antibody in a relatively straight forward synthetic process,” Jason Brady, senior director of Business Development at the firm told BioProcess Insider.
Unlike other bioconjugation technologies available, AJICAP “does not require genetic modification of the antibody, nor does it require any esoteric chemistry to achieve a drug-to-antibody ratio (DAR) of two,” he continued.
“Conventional ADCs which are currently commercially available are produced as heterogeneous mixtures containing a randomly determined 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.
As such, the technology can easily be transferred to the production line “since it shows high productivity and short conjugation reaction times, which all lead to an ease of manufacture,” he said.
The ADC space is estimated to expand at nearly 20% CAGR until 2030, with 17 new drugs in late stage development, and double-digit approvals of ADCs over next three years, according to this year’s CPhI Annual Report.
Furthermore, the outsourcing of ADC manufacturing is expected to rise past 70% of overall manufacturing, driven by increased biotechs and smaller companies in the pipeline needing specialist development expertise and facilities.
Brady told us his firm has entered the space as “oncology continues to be the fastest growing segment of the biopharmaceutical market, and ADCs are rapidly growing class of the oncology therapeutics.”
He reiterated the findings of the report, saying demand is primarily coming from emerging biotech and mid to large pharmaceutical companies with a focus in oncology therapeutic development.
While Aji Bio-Pharma has not divulged its investment in the technology, Brady said the platform emerged from Ajinomoto’s internal Research & Development organization in Kawasaki, Japan and the firm has trained and recruited staff capable of working with clients to test the technology.