The US Food and Drug Administration (FDA) has granted approval for Ajinomoto Bio-Pharma Services’ high potency vial line to manufacture a commercial product.
Currently, the company has six fill finish lines in San Diego, US, that includes a new line which provides various configurations, such as vials, cartridges, and prefilled syringes.
Ajinomoto Bio-Pharma stated that the high-speed process is rated to move up to 22,000 syringes an hour through the line, with more than 200 thousand syringes per batch capacity.
It also noted that this multi-purpose fill line is designed to meet the commercial compliance of FDA and EMEA.
Ajinomoto Bio Pharma Services US president and chief operating officer Bert Barbosa said: “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.
“As a leading global CDMO, we are dedicated to providing high-quality drug process development and manufacturing services to biotechnology and pharmaceutical companies worldwide.”
The company is a completely integrated contract development and manufacturing organisation that offers cGMP API manufacturing, comprehensive development, and aseptic fill finish services for molecule APIs and intermediates.
It provides a wide range of innovative platforms and capabilities, including oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), Corynex protein expression technology, continuous flow manufacturing, biocatalysis, and many more.