Country for PR: United States
Contributor: PR Newswire New York
Wednesday, April 19 2023 - 22:05
AsiaNet
Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line
SAN DIEGO, April 19, 2023 /PRNewswire-AsiaNet/ --

Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), 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.

Logo - https://mma.prnewswire.com/media/751177/Aji_BioPharma_Logo.jpg 

"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(R) 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. Learn more: www.AjiBio-Pharma.com

SOURCE: Ajinomoto Bio-Pharma Services

CONTACT: info@us.ajibio-pharma.com
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