SANTA ANA, Calif.--(BUSINESS WIRE)--Irvine Scientific, a member of JX Holdings group, announced today that it has shipped the first products manufactured to customers from its Industrial Cell Culture media production facility in Tokyo, Japan. 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 meters of a facility designed to replicate the production and processes used at the Company’s Santa Ana, CA 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, CA 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, CA and will bring the total capacity at both sites to over 1.2 million KG / year.
Irvine Scientific, a member of JX Holdings group, is a worldwide leader in the design, manufacture and distribution of medical devices, including Industrial Cell Culture, Cytogenetic, Assisted Reproductive Technology (ART) and Specialty Media products. Irvine Scientific is a large scale producer of advanced quality cell culture media for the industrial bioprocess, medical, and diagnostic markets. The company’s extensive experience in the design of culture media, compliance with ISO and FDA regulations for class II / III medical devices, industrial scale manufacturing capacity, provides its customers with unique capabilities and support. Irvine Scientific delivers products worldwide to biopharmaceutical industry, research and medical laboratory communities.
For more information about this topic or to schedule an interview with Tim Mullane, contact Ms. Makenzie Carter, at +949-261-7800 X202 or mcarter@irvinesci.com
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