Ajinomoto Bio-Pharma Services, a provider of biopharmaceutical contract development and manufacturing services, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s high potency vial line to manufacture a commercial product.

“Receiving FDA approval on our HPAPI 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,” said Bert Barbosa, president amd chief operating officer, Ajinomoto Bio Pharma Services, US. “As a leading global CDMO, we are dedicated to providing high-quality drug process development and manufacturing services to biotechnology and pharmaceutical companies worldwide.”

Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line that offers a range of configurations, including prefilled syringes, cartridges, and vials. The high-speed process is rated to move up to 22,000 syringes per hour through the line, with a batch capacity of over 200 thousand syringes. This multi-purpose fill line has been designed to meet FDA and EMEA commercial compliance.