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The Worlds First Commercially-Licensed Gene Therapy Drug Produced In NBS CelliGen Plus Packed-Bed Bioreactor
Investor Contact Samuel Eichenbaum Vice President, Finance 732-650 -2500 E-mail: same@nbsc.com
NBS Bioreactor Technology Contact Mike Sattan Director, Marketing 732-650-2011 E-mail: msattan@nbsc.com
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 Dr. Zhaohui Peng, SiBionos founder and CEO, NBS packed -bed bioreactor was selected because of its ability to produce extremely high quantities of secreted products, as many as 2 x 10 15 viral particles using a 14 L autoclavable vessel. NBS senior cell culture scientist and principal designer of the packed-bed basket, Dr. Guozheng Wang , explained that the CelliGen Plus utilizes 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 2.2 130 liter configurations. About Gendicine Gendicine was used in clinical trials on patients with late-stage HNSCC. After 8 weeks of therapy involving 1 injection per week, 64% of patients tumors experienced complete regression and 32% experienced partial regression. In combination with chemo - and radiotherapy, Gendicine improved treatment efficacy more than 3-fold. Over more than three years of follow-up, no patient relapsed. Unlike the gene therapies using retroviral vector delivery systems which led to complications, and ultimately the halt of further clinical trials in the US, Gendicine uses an adenoviral vector + p53 tumor suppressor gene delivery system, with the only side effect being grade I or II self-limited fever. Applications for gene therapy are far-reaching, with the potential to eventually cure diseases such as cancers, coronary artery disease, genetic diseases, AIDS and other health problems. With only a decade of clinical trials as its history, gene therapy has built enormous momentum in the fields of medicine and healthcare, because of its ability to precisely deliver therapeutic genes at the site of the disease and express the therapeutic protein . This precise localization of therapeutics is thought to be among the most effective means to guarantee sufficient levels of the therapeutics in the target tissue of the patient, without the risk of toxicity elsewhere in the body. David Freedman, New Brunswick Scientifics Chairman and CEO, summarized this groundbreaking news by stating, our cell culture technology has been well received throughout the world and has been successfully used to produce a large variety of antibiotics, vaccines and other products within the pharmaceutical and immunology fields. We are very proud that our equipment played a part in this latest, exciting medical breakthrough. New Brunswick Scientific Co., Inc. designs and manufactures a wide va riety of research equipment and scientific instruments for the life sciences with particular orientation towards equipment used to develop and manufacture vaccines, antibiotics and therapeutic products for human and animal healthcare.
This press release ncludes statements that may constitute forward-looking statements made i pursuant to the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995. This information may involve risks and uncertainties that could cause actual results to di ffer materially from the forward-looking statements. Although the Company believes that the expectations reflected in such forward -looking statements are based on reasonable assumptions, such statements are subject to risks and uncertainties that could cau se actual results to differ materially from those projected. Further information concerning risk factors is described in the Companys Securities and Exchange Commission filings.
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