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FDA Approves First Drug Using AJIPHASE Production Process

AJIPHASE platform is for the development and cGMP manufacture of high quality and purity commercial quantities of oligonucleotides and peptides.

By: Contract Pharma

Contract Pharma Staff

Ajinomoto Bio-Pharma Services, a provider of biopharmaceutical contract development and manufacturing services, announced that the U.S. FDA has approved the first commercial drug manufactured leveraging Aji Bio-Pharma’s 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.

The AJIPHASE technology is highly scalable (μg to 200 kg) providing cost-effective and pure oligonucleotides and peptides, with less waste byproducts, according to the company.

“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.”

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