PR99964

SAN DIEGO, April 19, 2023 /PRNewswire=KYODO JBN/ --

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.

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"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