SAN DIEGO, April 19, 2023 /PRNewswire/ — Ajinomoto Bio-Pharma Services (“Aji Bio-Pharma”), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the US Drug and Food of the United States (FDA) has approved the company’s line of high-potency vials for manufacturing a commercial product.
“Receiving FDA approval for our HPAPI fill line is an exciting milestone for our company, and it could not have happened without the hard work, hours of preparation, diligence, and support from the Aji Bio-Pharma team throughout As a global CDMO leader, we are dedicated to providing high-quality drug process development and manufacturing services to pharmaceutical and biotech companies around the world,” said Bert Barbosa, President and Chief Operating Officer of Ajinomoto Bio Pharma Services, USA
Aji Bio-Pharma has six fill-finish lines located in San Diego, including a new line that offers a variety of configurations, including pre-filled 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 more than 200,000 syringes. This multipurpose filling line has been designed to comply with FDA and EMEA trade regulations.
About Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, USA, Japan, and India, providing end-to-end development, cGMP API manufacturing, and aseptic fill-finishing services for APIs and molecule intermediates. small and big. Ajinomoto Bio-Pharma Services offers a wide range of innovative platforms and capabilities for pre-clinical and pilot programs in commercial quantities, including High Potency API (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 the needs of our customers. More information at: www.AjiBio-Pharma.com
Logo – https://mma.prnewswire.com/media/751177/…
View original content: https://www.prnewswire.com/news-releases/ajinomoto-bio-pharma-services-recibe-la-aprobacion-de-la-fda-para-la-linea-de-llenado-de-alta-potencia-301801570.html
