First Commercial Drug Manufactured via Ajinomoto Bio-Pharma Services' AJIPHASE Technology Receives FDA Approval

Ajinomoto Bio-Pharma Services

PR85965

 

TOKYO, Oct. 7, 2020 /PRNewswire=KYODO JBN/ --

 

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

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