| 초록 |
The mammalian cell culture technique is one of the most important biotherapeutic production techniques which are in high demand recently. Celltrion Inc is constructing a state-of-the-art commercial cell culture bulk pharmaceutical cGMP facility on a 92,500 square meter in Incheon, South Korea. Manufacturing suite in Incheon consists of four 12,500 L production bioreactors. These facilities will be mechanically completed in Dec. 2004, and will be validated in cGMP compliance by mid-2005. The facility is used to manufacture therapeutic recombinant proteins and Mabs designed to meet US FDA as well as EU standards. Celltrion provides a complete development package, taking a product from vector construction and cell line development through to full-scale manufacture, including a full range of analytical services and regulatory support for clinical trials and in market supply through a fully integrated cGMP manufacturing services for the biotechnology and biopharmaceutical industries utilizing mammalian cell culture to support pre-clinical, clinical phase and commercial production. Celltrion can offer the advantages of lower cost structure, the assurance of intellectual property protection, and high-quality, U.S.-based technology transfer for process development and manufacturing. |
