Ajinomoto Bio-Pharma Services a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the United States 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. As a leading global CDMO, we are dedicated to providing high-quality drug process development and manufacturing services to biotechnology and pharmaceutical companies worldwide." said Bert Barbosa, President & COO, Ajinomoto Bio Pharma Services, US.
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.
About Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP API manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including high potency APIs (HPAPI), continuous flow manufacturing, oligonucleotide synthesis, biocatalysis, Corynex® protein expression technology, antibody drug conjugations (ADC) and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client's needs.