130,000 sq.ft. facility
Licensed aseptic GMP facility
GLP analytical laboratories
Research and Development Facilities
Large scale extraction and purification facility
Multidisciplinary teams of various scientific expertise.
Biolyse Pharma Corp. is a research driven, fully integrated pharmaceutical company headquartered in St.Catharines, Ontario.
Biolyse Pharma is dedicated to the manufacturing, marketing, distribution and research of anti-cancer drugs.
To take a leading role in reducing the cost of medicine.
To offer additional treatment options to patients thus making a positive difference in their lives.
To blaze a trail for future victories against cancer through research and development.
The company's debut dates back to the 1980's when a few enthusiastic researchers provided laboratory services in order to fulfill their passion for researching the bioactivity of rare natural extracts.
Remaining attentive to the critical needs of the health care market, the Biolyse team continually assessed and explored solutions that showed promise to make a positive difference to patients.
In the late 1980's the Biolyse team became aware of the U.S. National Cancer Institute's industry wide appeal to find an alternative to the Pacific yew tree (Taxus brevifolia or Western yew) as a source of the promising anti-cancer compound Paclitaxel. The bark of the Pacific yew was used to derive the compound, but excessive harvesting was fast depleting this natural resource.
Biolyse was the first company to discover that Paclitaxel could be produced by using only the needles and small twigs of the much more plentiful Eastern yew (Taxus canadensis). The non-destructive harvesting and innovative production methods permitted a renewable and very abundant source of paclitaxel. This discovery, was of tremendous importance to the future availability of this naturally based oncology product at a reasonable cost.
Since research and development had always been a core activity for Biolyse, taking the risk of bringing this new drug to the marketplace seemed to be a natural progression for Biolyse.
Biolyse actively distributes its oncology drug to small and major Canadian cancer centres as well as to ever expanding international markets.
Biolyse has business partnerships with pharmaceutical and distribution companies that include technology transfer, marketing and licensing agreements and research and development projects.
Biolyse continues to actively explore innovative medicines through diverse and ongoing research and development programs.
Paclitaxel is a substance utilised in the formulation of an anticancer drug. It was originally obtained from the bark of the Pacific yew tree, a very slow growing specie which has been declared endangered due to high demand for the drug and the excessive harvesting which followed.
First discovered in the early 1970`s, this extract was subjected to intensive research to investigate its potential as an anticancer drug with a unique, and previously unknown mechanism of action. Demonstration of its usefulness in the treatment of advanced ovarian and breast cancer was largely due to the efforts of scientists and cancer experts at the National Cancer Institute in the USA. Since then paclitaxel is used worldwide in the treatment various other types of cancer.
Because of the growing scarcity of naturally occurring paclitaxel from Taxus brevifolia, efforts were made to find alternate sources of extracts suitable for drug manufacturing. While other companies were working on a synthetic approach, Biolyse Pharma was the first group to discover that paclitaxel could be extracted using only the needles of a parent specie (Taxus canadensis) which is commonly found in Ontario, Quebec and northern New-Brunswick. This discovery, which predated the involvement of all other current producers of Paclitaxel, was of tremendous importance to the future availability of this oncology product at a fair cost to the health care system. Biolyse Pharma developed a technology for the extraction of paclitaxel from Taxus canadensis to the point that it is now commercially exploited on a scale sufficiently large to meet national and international markets.
Biolyse has put this discovery to practical use. In 1994, the product was approved for clinical trial following an Investigational New Drug submission (IND). The clinical trial program initiated in major hospital centres in Quebec and Ontario was completed in 1998 and the product was approved for commercialisation in 2001. Biolyse Pharma has been producing Paclitaxel since the late 1980's.
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Single vial formulation at a strength of 20 mg/mL. Available in presentations of 1 mL (pack of 10), 4 mL (pack of 10) and 8 mL (pack of 5).
Strength of 50 mg/mL. Available in single use vials of 10 mL and multi-use vials of 100 mL (single pack).
Biolyse Pharma offers GMP custom aseptic sterile filling services, primarily to pre-clinical and phase I drug companies.
Biolyse understands that research and development is not only essential to the advancement of health care but also vital to ensure the future of its own operations.
Biolyse is presently focusing its research on several pharmaceutical developments which are destined to result in innovative cancer treatments. Biolyses' research goal is principally focused on anticipated therapies that will increase treatment options for both patients and their treating physicians. By pursuing the research and development approach that led to its paclitaxel product, Biolyse turns once again to nature to discover further naturally occurring substances with potential anti-tumoral capabilities. Selected research projects at Biolyse cover a wide variety of activities that can range from experimental farming, to elaborate separation and purification technologies.
An ongoing Biolyse project is the development of a natural compound that has been shown to target tumour cells more selectively than currently available cancer therapies. The potential success of bringing this drug to market would lead to an enhanced treatment that both selectively decreases migration of cancer cells but also inhibits toxicity to normal cells.
59 Wellandvale Rd.
St. Catharines, Ontario,
Canada L2S 3Y2
Tel: 905 687 8008
Fax: 905 687 4923
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