Aji Bio receives FDA approval for commercial oligo process

Ajinomoto Bio-Pharma Services’ AJIPHASE Technology has received US FDA approval for an undisclosed commercial oligonucleotide, most likely NS Pharma’s Viltepso (viltolarsen).

The announcement highlights Aji’s AJIPHASE synthesis technology in its potential to scale up oligonucleotide production.

“AJIPHASE is used in the development and cGMP manufacture of large-scale oligonucleotides and peptides,” a spokesperson from the company told this publication. “The AJIPHASE technology employs the use of an anchor, instead of a resin, which provides a homogeneous mixture. After the reaction occurs, the anchor, which is very not soluble in polar solvents, precipitates and is filtered out with the excess reagents and byproducts, providing the recovered intermediate, all in one reactor.”

Image: iStock/tang90246

The firm is able to perform AJIPHASE manufacturing at its Belgium and Japan (Tokai) facilities.

“With no additional special equipment, we are able to scale to 200 kg under cGMP with less solvents and reagents required (therefore less waste byproducts), providing our customers with cost savings. Quality and purity profiles show no difference between AJIPHASE and traditional solid phase synthesis.”

The contract development and manufacturing organization (CDMO) told us the customer could not be divulged. However, US Food and Drug Administration (FDA) labeling information names Ajinomoto Co., Inc as the API manufacturer for NS Pharma’s Viltepso (viltolarsen).

Viltepso received FDA approval in August for Duchenne muscular dystrophy (DMD) patients whose disease is characterized by a particular genetic mutation.

The labeling information also names Fuji Yakuhin, Nippon Shinyaku, and YMC as manufacturers of the oligonucleotide drug.