Ajinomoto HPAPI Line Receives FDA Approval

Ajinomoto Bio-Pharma Services, a contract development and manufacturing organization (CDMO), noted that FDA has approved the company's high potency vial line to manufacture a commercial product.

When it comes to its US facilities, the CDMO has six fill-finish lines located in San Diego, including a new, multi-purpose line that has been designed to meet FDA and EMEA commercial compliance. It offers various configurations, including pre-filled syringes, cartridges, and vials. The high-speed process can move up to 22,000 syringes per hour through the line, with a batch capacity of over 200,000 syringes.

"Receiving FDA approval on our HPAPI [highly potent active pharmaceutical ingredients] fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of preparation, diligence and support from the Aji Bio-Pharma team across our whole organization, comments Bert Barbosa, president & COO, Ajinomoto Bio Pharma Services, US. “… We are dedicated to providing high-quality drug process development and manufacturing services to biotechnology and pharmaceutical companies worldwide."