Gil Roth10.30.13
DSM Pharmaceutical Products has officially opened its cGMP bio-CMO facility in Brisbane, Australia. The facility was built in partnership with Biopharmaceuticals Australia with cooperation from the government of Queensland and the Commonwealth of Australia. The Asia-Pacific region is an important growth area in DSM's strategic development in the biopharma field, according to a company statement.
The facility was designed by an international team of biological scientists and bioengineers, utilizing DSM's 27 years of experience in mammalian cell culture processing to construct a purpose-built, state-of-the-art biomanufacturing facility. The Brisbane facility offers cGMP mammalian cell culture contract manufacturing services from process development through to commercial manufacturing. The Brisbane facility has an output capability of 500kg and has expansion space available for further capacity utilization. In June of this year the Brisbane site was thoroughly assessed by inspectors from TGA (Therapeutic Goods Act). CGMP commercial production is expected to begin in January 2014.
Lukas Utiger, president and chief executive officer of DSM Pharmaceutical Products, commented, "With its flexible design and use of single-use technology, the facility represents the model for the future of biomanufacturing. It represents an important milestone in the development of Australia-based mammalian cell-based manufacturing of biopharmaceuticals, and extends DSM's contribution to the global biotechnology market."
In conjunction with the opening, DSM Pharmaceutical Products has announced a manufacturing agreement with Opthea Pty Ltd of Melbourne, Australia. The contract covers process development and cGMP manufacture by DSM for Opthea's lead molecule, a soluble form of human VEGFR-3 that blocks the activity of both VEGF-C and VEGF-D, which promote blood and lymphatic vessel formation and are involved in the progression of eye diseases.
This project represents an agreement for process development at DSM Biologics’ Groningen, The Netherlands, facility and manufacture at the Brisbane facility. DSM previously announced contracts for the Brisbane site with DecImmune Therapeutics of Cambridge, MA; RECEPTA Biopharma in São Paulo, Brazil; and Paranta Biosciences of Melbourne, Australia.
The facility was designed by an international team of biological scientists and bioengineers, utilizing DSM's 27 years of experience in mammalian cell culture processing to construct a purpose-built, state-of-the-art biomanufacturing facility. The Brisbane facility offers cGMP mammalian cell culture contract manufacturing services from process development through to commercial manufacturing. The Brisbane facility has an output capability of 500kg and has expansion space available for further capacity utilization. In June of this year the Brisbane site was thoroughly assessed by inspectors from TGA (Therapeutic Goods Act). CGMP commercial production is expected to begin in January 2014.
Lukas Utiger, president and chief executive officer of DSM Pharmaceutical Products, commented, "With its flexible design and use of single-use technology, the facility represents the model for the future of biomanufacturing. It represents an important milestone in the development of Australia-based mammalian cell-based manufacturing of biopharmaceuticals, and extends DSM's contribution to the global biotechnology market."
In conjunction with the opening, DSM Pharmaceutical Products has announced a manufacturing agreement with Opthea Pty Ltd of Melbourne, Australia. The contract covers process development and cGMP manufacture by DSM for Opthea's lead molecule, a soluble form of human VEGFR-3 that blocks the activity of both VEGF-C and VEGF-D, which promote blood and lymphatic vessel formation and are involved in the progression of eye diseases.
This project represents an agreement for process development at DSM Biologics’ Groningen, The Netherlands, facility and manufacture at the Brisbane facility. DSM previously announced contracts for the Brisbane site with DecImmune Therapeutics of Cambridge, MA; RECEPTA Biopharma in São Paulo, Brazil; and Paranta Biosciences of Melbourne, Australia.