FDA Approves Ajinomoto Bio-Pharma Services' High Potency API Filling Line

 Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, today announced that the U.S. Food and Drug Administration (FDA) has approved the manufacture of commercial products on its high potency drug substance vial filling line. .


Ajinomoto Bio-Pharma Services has six fill and finish lines in San Diego, USA, of which the new line will offer a wide range of fill and finish formats, including prefilled syringes, cartridges and vials. This high-speed process is rated to run up to 22,000 syringes per hour on line, and is capable of batch processing over 200,000 syringes, meeting FDA and EMEA commercial compliance designed.

Bert Barbosa, president and COO of the company, said: “The FDA approval of our highly active active pharmaceutical ingredient (HPAPI) filling line is an exciting milestone for us, due to the tremendous effort, dedication, care and support of our entire organization as the Aji Bio-Pharma team. As one of the world's leading contract development and manufacturing organizations (CDMOs), we are committed to providing high-quality pharmaceutical process development and manufacturing services to biotechnology and pharmaceutical companies worldwide."

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