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The new facility, located in Saitama prefecture, has the capacity to manufacture animal component free cell culture media in volume requirements ranging from research uses to production of biopharmaceuticals and vaccines. The facility has been commissioned and validated as completely animal component free (ACF).
Irvine Scientific is a worldwide media provider that is regulated and adheres to both ISO and FDA regulations. The Irvine Scientific Tokyo facility is designed for maximum efficiency and to meet the highest quality cGMP standards.
The new site currently occupies 1,720 square metres of a facility designed to replicate the production and processes used at the company’s Santa Ana, California manufacturing facility. The Tokyo site has state-of-the-art formulation and packaging equipment, and utilizes continuous milling and blending equipment designed and built to Irvine Scientific specifications. The facility will further secure Irvine Scientific’s flexible customer-centric approach to media supply.
The Tokyo site has room to expand as needed to meet customer demands. This expanded capacity and system redundancy to the existing site in Santa Ana provides customers with the security and redundancy of supply that they require in the later product stages. The systems and location are ideally suited to serve Irvine Scientific's growing customer base in Japan and Asia.
The Tokyo and Santa Ana sites use identical equipment and processes along with consistent raw materials, which assure that the media produced in either location adheres to agreed upon customer expectations and regulatory quality system requirements. The Tokyo facility capacity doubles Irvine Scientific's current powder manufacturing capacity at Santa Ana, California, USA and will bring the total capacity at both sites to over 1.2 million Kg/year. |
