FDA approved the first commercial drug manufactured via Aji Bio-Pharma's proprietary production process.
Ajinomoto Bio-Pharma Services, a biopharmaceutical contract development and manufacturing services provider, announced in an Oct. 6, 2020 press release that the US FDA has approved the first commercial drug manufactured using the company’s proprietary Ajiphase production process. This proprietary synthesis technology was originally developed for peptide synthesis and has expanded to include oligonucleotide production.
"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, in the press release.
The Ajiphase platform is a hybrid of traditional solid-phase and solution-phase synthesis that uses an anchor in place of a resin for the development and manufacture of high quality and purity commercial quantities of oligonucleotides and peptides. The technology is highly scalable (µg to 200 kg). Compared to traditional solid-phase synthesis, the technology uses less solvents and reagents.
Source: Ajinomoto Bio-Pharma Services
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.