FDA Approves First Commercial Drug Manufactured via Ajinomoto AJIPHASE Technology

Ajinomoto Bio-Pharma Services announced the U.S. Food and Drug Administration (FDA) has approved the first commercial drug manufactured via Ajinomoto Bio-Pharma’s proprietary AJIPHASE® production process.

Originally developed for peptide synthesis, the AJIPHASE synthesis technology has expanded to include oligonucleotide production. A hybrid of traditional solid phase and solution phase synthesis, using an anchor in place of a resin, AJIPHASE is a proven platform for the development and cGMP manufacturing of high quality and purity commercial quantities of oligonucleotides and peptides.

“We are excited to be able to provide this drug to our partner and support them in their efforts to supply a lifesaving therapeutic,” said Wataru Kurosawa, Manager, AJIPHASE Group, Ajinomoto Bio-Pharma Services. “Our AJIPHASE technology is great example of Aji Bio-Pharma providing reliable and innovative solutions to our clients.”

The technology is scalable (μg to 200 kg) providing cost-effective and pure oligonucleotides and peptides, with less waste byproducts. The AJIPHASE technology uses less solvents and reagents, while providing high purity and equivalent quality, high yield batch sizes.

“We are excited to be able to provide this drug to our partner and support them in their efforts to supply a lifesaving therapeutic,” said Wataru Kurosawa, Manager, AJIPHASE Group, Ajinomoto Bio-Pharma Services. “Our AJIPHASE technology is great example of Aji Bio-Pharma providing reliable and innovative solutions to our clients.”