08 December 2022 | Thursday | News
Thermo Fisher Scientific, the world leader in serving science, is opening a new facility in Hangzhou, China, as part of its global effort to help companies provide therapies to patients more quickly. The site can address the needs of organizations in China, as well as those outside that country, for biologics and steriles development and manufacturing capabilities in the Asia-Pacific region.
"Hangzhou is a strategic addition to our global pharma services network and the latest example of our commitment to meeting customer demands globally,” said Mike Shafer, senior vice president and president, Pharma Services. “We continue to invest in capabilities to support the manufacturing needs of our customers, enabling them to serve more patients throughout the world.”
The 80,000-square-meter current Good Manufacturing Practices (cGMP) facility will offer integrated clinical and commercial drug substance and drug product capabilities, including process development, cell line development, biologics drug substance manufacturing and sterile fill-finish. Eventually, it will also feature commercial packaging and labeling capabilities. Advanced technologies in the facility include Thermo Fisher 2,000-liter HyPerforma Single-Use Bioreactors and associated Single-Use equipment and, in the future, bioreactor capacity up to 5,000 liters through Thermo Scientific DynaDrive technology.
The site incorporates stringent quality control processes that meet or exceed regulatory guidelines established by the China National Medical Products Administration (NMPA), the U.S. Food and Drug Administration, and authorities in Europe and elsewhere.
“Thermo Fisher has been in China for 40 years, serving this market through its bioproduction, clinical research and pharma services businesses,” said Hann Pang, president, Thermo Fisher China. “Committed to our ‘in China, for China’ localization strategy, we are enhancing our workflow capabilities to fully support pharmaceutical and biotechnology companies in China and worldwide in helping more local innovations go global.”
The Hangzhou site is representative of the global scale of Thermo Fisher’s comprehensive end-to-end, contract development and manufacturing capabilities. With this facility and Thermo Fisher’s current capabilities in clinical packaging and logistics, the company can now offer a seamless end-to-end solution from molecule development through the accelerated delivery of critical medicines to patients.