Country for PR: United States
Contributor: PR Newswire New York
Wednesday, October 07 2020 - 02:17
AsiaNet
First Commercial Drug Manufactured via Ajinomoto Bio-Pharma Services' AJIPHASE Technology Receives FDA Approval
TOKYO, Oct. 7, 2020 /PRNewswire-AsiaNet/ --

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(R) production process.

Logo - https://mma.prnewswire.com/media/751177/Aji_BioPharma_Logo.jpg

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(R) 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

SOURCE Ajinomoto Bio-Pharma Services

CONTACT: info@us.ajibio-pharma.com
Translations

Japanese