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