YOKOHAMA, Japan, July 29 (Bernama) -- Ahead of the official opening of AGC Biologics’ Yokohama site, an international biopharmaceutical company has already secured half of the facility’s mammalian manufacturing capacity with a multi-year commercial contract expected to reach hundreds of millions of dollars in total value. The Contract Development and Manufacturing Organization (CDMO) will leverage its new Yokohama facility to manufacture a minimum of 35 batches per year of five biopharmaceutical products for the undisclosed customer, securing a reliable global supply chain for patients worldwide.
The agreement includes process transfer, scale-up, regulatory validation, and future commercial production. The customer will pursue multiple regulatory approvals with the EMA, FDA, MHRA, and PMDA. The aggressive manufacturing timeline includes four process performance qualifications (PPQ) campaigns in the first two years.