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.”
À propos d'Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services est une organisation de développement et de fabrication sous contrat (CDMO) entièrement intégrée, disposant de sites en Belgique, aux États-Unis, au Japon et en Inde. Elle propose des services complets de développement, de fabrication conforme aux normes cGMP et de conditionnement aseptique pour les principes actifs pharmaceutiques (API) de petite et grande taille ainsi que pour les intermédiaires. Ajinomoto Bio-Pharma Services propose un large éventail de plateformes et de capacités innovantes, allant des programmes précliniques et pilotes jusqu’aux quantités commerciales, notamment la technologie d’expression protéique Corynex®, la synthèse d’oligonucléotides, les conjugués anticorps-médicaments (ADC), les principes actifs pharmaceutiques à haute puissance (HPAPI), la biocatalyse, la fabrication en flux continu et bien plus encore. Ajinomoto Bio-Pharma Services s’engage à fournir un niveau élevé de qualité et de service afin de répondre aux besoins de ses clients. Pour en savoir plus : www.AjiBio-Pharma.com
