About Us
Biolyse Pharma’s Comprehensive Capabilities
Biolyse Pharma’s wide range of capabilities enables us to deliver competitively priced pharmaceutical products and services. From manufacturing to distribution, we ensure that our products meet the highest standards of quality, safety and efficacy
Our capabilities include state-of-the-art manufacturing facilities, stringent quality control processes, and a dedicated team of experts.
Our Facility
Biolyse’s facility spans 130,000 square feet and accommodates GMP licensed sterile and non-sterile production areas, accredited analytical laboratories as well as capacities dedicated to research and development.
Our Team
At Biolyse, diverse scientific professionals are dedicated to ensuring the safety, efficacy, and continuous supply of our products.
Our Culture
Integrity lies at the heart of our operations, as we steadfastly aim to uphold the highest standards of ethics and compliance.
Our Mission
Our mission is to ensure the continued distribution of our life-saving medicines while simultaneously pioneering innovative and effective treatments to enrich the lives of patients worldwide.
Our Future
While we prioritize our licensed products, Biolyse Pharma is equally dedicated to advancing into the development of biologic medications. Committed to collaborating with the pharmaceutical industry, we strive to develop future products, processes, and services that benefit patients worldwide.
Our biologics facility presently in its last stage of completion, will expand our capabilities to produce large molecules such as monoclonal antibodies, therapeutic peptides, and immunologic modulators.
Our History
Dr. Wall, alongside his colleague Dr. Mansukh C. Wani, conducted extensive research at the Natural Products Laboratory of the Research Triangle Institute during the 1960s and 1970’s, investigating thousands of plant and animal extracts for potential cancer treatments. Their groundbreaking work led to the discovery of paclitaxel and camptothecin, both potent antitumor agents.
Paclitaxel was originally identified and sourced from the bark of the Pacific yew tree, (Taxus brevifolia), the extraction process proved challenging and environmentally concerning due to the species’ slow maturation leading to unsustainable harvesting practices endangering the species.
Fortunately, Biolyse identified an innovative solution by deriving paclitaxel from the Eastern yew (Taxus canadensis) utilizing only clippings of small twigs and needles. This breakthrough provided a renewable and abundant source for the vital drug, addressing both environmental and supply concerns.
In September 1994, Biolyse received authorization from the Federal Health Protection Branch (HPB) to administer its Paclitaxel for Injection to patients under a clinical trial program, marking a significant milestone in ensuring continued access to the drug.
The marketing authorization for Paclitaxel for Injection was granted based on the proven effectiveness and safety demonstrated through clinical trials conducted under the supervision of leading Canadian oncology centers.
Biolyse’s pioneering discovery predates the availability of any other paclitaxel formulation, highlighting its crucial role in maintaining the drug’s supply. Over the past two decades, Biolyse has amassed valuable experience with Taxoids (paclitaxel and docetaxel) that are still considered a new class of chemotherapy agents.
Today, ongoing efforts to explore new sources for paclitaxel have led to the development of semi-synthetic methods for producing this complex molecule, further diversifying its supply chain and ensuring its availability for cancer patients worldwide.
© 2024 Biolyse