Pharmabiz
 

Bioniche Life Sciences opens new animal health and food safety vaccine manufacturing centre in Canada

Belleville, OntarioMonday, May 02, 2011, 12:00 Hrs  [IST]

Bioniche Life Sciences Inc. a research-based, technology-driven Canadian biopharmaceutical company, officially opened its new Animal Health and Food Safety Vaccine Manufacturing Centre at its corporate headquarters in Belleville, Ontario, Canada. This facility represents the largest livestock vaccine manufacturing facility in Canada, with capacity to supply Canadian animal vaccine requirements and to meet international regulatory standards (Good Manufacturing Practice – GMP).

This expansion provides Bioniche with the capability to produce a wide spectrum of vaccines, with fermentation capabilities of up to 5,000 litres and all downstream processing and supporting utilities. The project was made possible through financial support from the following government agencies:
Ontario Ministry of Economic Development & Trade (Advanced Manufacturing Investment Strategy Programme) - $10 million repayable contribution Agriculture & Agri-Food Canada (Agri-Opportunities Programme) - $5 million repayable contribution Business Development Bank of Canada - $5 million repayable contribution Industry Canada (Industrial Technologies Office) - $5 million repayable contribution.

“This government funding was critical to achieve our vision for a state-of-the-art Canadian vaccine manufacturing facility to produce a range of vaccines to prevent illnesses in animals and to reduce the likelihood of human illness from animal diseases,” said Graeme McRae, chairman, president & CEO of Bioniche Life Sciences Inc. “We are proud of our internal Manufacturing Operations team that worked with a Montreal-based engineering firm and a Belleville-based general construction contractor to complete the project. Approximately 90% of the equipment purchased for the facility was made in Canada.”

“The Animal Health and Food Safety Vaccine Manufacturing Centre has been designed and built to meet the highest manufacturing standards for future supply of animal vaccines into global markets,” said Mohamed Elrafih, vice-president of Manufacturing Operations at Bioniche Life Sciences Inc. “19 employees have been hired for the Vaccine Manufacturing Centre to date, with a further 7 employees recently hired in other areas of the facility in indirect support positions. An additional 15 to 20 employees are expected to be hired over the next 18 months.”

Once fully commissioned, the first product to be manufactured in the Centre will be the Company's E. coli O157 cattle vaccine - Econiche - directed to reducing the level of this deadly pathogen in water, food and the environment and, in turn, help minimize the potential for infection of humans.

The E. coli O157 organism causes no disease in cattle, but cattle are the primary reservoir for it. E. coli O157 can cause severe illness and can even be fatal when ingested by humans from contaminated meat, vegetables, other food products, or water. Human exposure and infection with E. coli O157 can result in serious health consequences, including abdominal pain and severe bloody diarrhoea. In severe cases, kidney damage can occur and progress to serious complications and even death. Lingering, long-term medical conditions can persist in individuals exposed to the bacterium. These include post-Infectious Irritable Bowel Syndrome (PI-IBS), reduced kidney function, diabetes, hypertension and reactive arthritis.

At the Official Opening of the Vaccine Manufacturing Centre today, the Company also recognized additional government support associated with its vaccine development. The Rural Economic Development (RED) Programme of the Ontario Ministry of Agriculture, Food and Rural Affairs provided a $2 million grant in 2007 to the company in support of market development related to the Company's E. coli O157 cattle vaccine. More recently (April, 2010), the Company received an investment of $750,000 (repayable loan) from the Federal Economic Development Agency for Southern Ontario (FedDev Ontario) for the development of a pilot-scale fermentation facility adjacent to the new Vaccine Manufacturing Centre. This facility houses fermentation equipment and downstream processing to allow small-scale, bench-top processes to be scaled up and readied for commercial-scale production in the Vaccine Manufacturing Centre.

The company has developed substantial strategic information (trade secret) expertise on inducing bacteria to produce commercial quantities of vaccination proteins during fermentation. These technologies may also be applicable to the development of additional animal health and food safety vaccines, including for Salmonella and Rhodococcus equi, for which the Company is already supporting research and development work.

The Food Safety Division of Bioniche Life Sciences Inc. has worked with Canadian university researchers, in particular, Dr Brett Finlay and his team at the University of British Columbia, to develop and license a cattle vaccine against E. coli O157. This vaccine - trademarked EconicheTM - is meant to reduce the level of the bacterium in water, food and the environment and, in turn, reduce the potential infection of humans. It has been fully licensed in Canada since October, 2008. A conditional license is pending in the US Econiche has the potential to significantly reduce the amount of E. coli O157 shed into the environment by beef and dairy cattle. This organism does not cause illness in cattle, but cattle are the primary reservoir for it. Vaccination of cattle with Econiche can help reduce the risk of food and waterborne contamination with E. coli O157.

Econiche has been developed by a strategic alliance formed in September, 2000 and composed of the University of British Columbia (UBC), the Alberta Research Council (ARC), the University of Saskatchewan's Vaccine & Infectious Disease Organization (VIDO), and Bioniche, which holds the rights for worldwide commercialization of the vaccine.

An estimated 100,000 cases of human infection with the E. coli O157 organism are reported each year in North America. Two to seven per cent of those people develop Haemolytic Uremic Syndrome (HUS), a disease characterized by kidney failure. Five percent of HUS patients die, many of them children and senior citizens, whose kidneys are more sensitive to damage.

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide.

 
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