First Commercial Drug Manufactured via Ajinomoto Bio-Pharma Services’ AJIPHASE Technology Receives FDA Approval
October 6, 2020 – Tokyo, Japan – Ajinomoto Bio-Pharma Services (“Aji Bio-Pharma”), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the US FDA has approved the first commercial drug manufactured via Aji 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 robust technology is highly scalable (µg to 200 kg) providing highly cost-effective and pure oligonucleotides and peptides, with less waste byproducts. When compared to traditional solid phase synthesis, the AJIPHASE technology uses less solvents and reagents, while providing high purity and equivalent quality, high yield batch sizes.
“We are very pleased that our AJIPHASE synthesis technology was able to meet the manufacturing and quality needs for our clients’ therapeutic,” said Yasuyuki Otake, Head of Japan, Ajinomoto Bio-Pharma Services. “And exemplifies our dedication in improving the health of humankind.”
About Ajinomoto Bio-Pharma Services
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. Learn more: www.AjiBio-Pharma.com