味の素バイオファーマサービスの「AJIPHASE」技術を用いて製造された初の市販薬が、FDAの承認を取得
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.”
味の素バイオファーマサービスについて
味の素バイオファーマサービスは、ベルギー、米国、日本、インドに拠点を置く完全統合型の受託開発・製造機関（CDMO）であり、低分子・高分子の原薬および中間体に対し、包括的な開発、cGMP準拠の製造、無菌充填・包装サービスを提供しています。 味の素バイオファーマ・サービスは、Corynex®タンパク質発現技術、オリゴヌクレオチド合成、抗体薬物複合体（ADC）、高活性原薬（HPAPI）、生体触媒、連続フロー製造など、前臨床およびパイロットプログラムから商業生産規模に至るまで、幅広い革新的なプラットフォームと能力を提供しています。 味の素バイオファーマ・サービスは、お客様のニーズに応えるため、高水準の品質とサービスの提供に尽力しています。詳細はこちら：www.AjiBio-Pharma.com
