Approval to produce the world's first commercially-licensed gene therapy medication, a treatment for head and neck squamous cell carcinoma, has been granted to SiBiono
New Brunswick Scientific reports that approval to produce the world's first commercially-licensed gene therapy medication, a treatment for head and neck squamous cell carcinoma (HNSCC), has been granted to the Shenzhen SiBiono Gene Technologies (SiBiono) using New Brunswick Scientific's CelliGen Plus bioreactor.
The drug license was issued on 16 October 2003 by the State Food and Drug Administration of China after more than five years of clinical trials, providing hope to about 300,000 new patients in China who are diagnosed with this malignancy each year.
HNSCC predominantly strikes men after age 50, and until now prognosis for survival had been poor, despite combined surgery and chemotherapy or radiation therapy.
Marketed under the name Gendicine, SiBiono's new drug is expected to become commercially available in January 2004, and with further testing, may prove effective in treating a wide range of cancers.
It is the first gene therapy drug in the world approved for sale in what is predicted to be a $100 million market in 2004.
SiBiono, founded in 1998, specialises in the development of gene therapy products for the treatment of a variety of cancers and cardiovascular diseases.
Their new 16,000 square foot cGMP (current good manufacturing practices)-compliant facility is equipped with expert staff and state-of-the-art equipment.
This new injectable medication, developed using an adenoviral vector, was first produced in roller bottles and parallel-plate reactor systems, before being approved for production using the NBS CelliGen Plus cGMP-compliant packed-bed perfusion bioreactor. According to Zhaohui Peng, SiBiono's founder and CEO, "NBS's packed-bed bioreactor was selected because of its ability to produce extremely high quantities of secreted products, as many as 2x1015 viral particles using a 14L autoclavable vessel".
NBS senior cell culture scientist and principal designer of the packed-bed basket, Guozheng Wang, explained that the CelliGen Plus utilises Fibra-Cel disks, a cell growth support matrix, which provides a very high surface area-to-volume ratio, enabling higher yields of biomass and therefore secreted products than competing microcarrier systems. The packed-bed design provides a low-shear, highly-oxygenated environment to facilitate cell growth, and is currently available in 2.2 - 130litre configurations.
