FDA okays first commercial drug manufactured via AJIPHASE technology

Originally developed by Ajinomoto for peptide synthesis, the technology has been expanded to include oligonucleotide production


Ajinomoto Bio-Pharma Services, a biopharmaceutical contract development and manufacturing organization (CDMO), reports that the U.S. Food and Drug Administration has approved the first commercial drug manufactured via the company’s proprietary AJIPHASE production process.

Originally developed for peptide synthesis, the AJIPHASE synthesis technology has been expanded to include oligonucleotide production. Oligonucleotides, commonly made in labs by solid-phase chemical synthesis, are used in a range of applications including genetic testing.

With a hybrid of traditional solid-phase and solution phase synthesis, using an anchor in place of a resin, the Ajinomoto AJIPHASE process platform allows for the development and cGMP manufacturing of high quality and purity commercial quantities of oligonucleotides and peptides, according to the company.

The scalable technology produces lower amounts of waste byproducts and uses fewer solvents and reagents when compared to traditional solid-phase synthesis.

Ajinomoto Bio-Pharma Services maintains sites in San Diego, Belgium, Japan and India.