ProMetic Mimetic Ligand Adsorbent Sucessfully Implemented In Large-Scale Biomanufacturing Process
ProMetic Life Sciences Inc. ("ProMetic") announces that its UK-based subsidiary, ProMetic BioSciences Ltd ("PBL"), in collaboration with a biomanufacturing client, has once more successfully implemented a large-scale purification bioprocess using a ProMetic Mimetic Ligand affinity adsorbent which has met all of its client's performance targets.
Approximately 800 liters of a commercial Mimetic Ligand product were packed and successfully operated in a 1.8 meter diameter process chromatography column. This column is to be used for the GMP manufacture of a biological product, providing highly purified material for the next phase of a clinical trials programme. Further details of this application were not disclosed for reasons of client confidentiality.
Currently, twelve different PBL bioseparation materials have been adopted for the manufacture of licensed biopharmaceuticals or form components of biomedical products approved for sale in the U.S. and/or Europe.
"The number of companies using ProMetic's bioseparation products for the manufacture of licensed biopharmaceuticals is set to grow rapidly as products at the clinical trials stage, which already incorporate PBL's technology for their production, progress to approval," said Dr. Steve Burton, PBL's Chief Executive Officer. Dr. Burton added, "The introduction of new products and the continued expansion of our client base, especially in the area of plasma proteins, are expected to provide a further increase in demand for PBL's bioseparation products. ProMetic is well-positioned to meet these demands, following past investments in its manufacturing facilities that provide increased production capabilities."
According to Dr. Dev Baines, PBL's Director of Research and Development, "The operation of chromatography columns at this scale requires higher performance resins with the necessary uniformity and rigidity to support high flow rates at high back- pressures. ProMetic's Mimetic Ligand product, designed for large-scale applications, has passed this challenge with flying colours".
The purification of biological products is commonly achieved by use of column chromatography, increasingly affinity chromatography, as this technique offers a cost-efficient method that increases product yields and purities. As the demand for biotherapeutic products increases, a market valued at over $70bn and growing at 14% per annum in the U.S. and Europe, the number of biological products and their scale of manufacture is growing rapidly. A direct consequence is the current trend toward larger batch sizes, larger chromatography columns, and increased amounts of chromatography resin. ProMetic's Mimetic Ligand products are ideally suited to such applications due to their high-selectivity and compatibility with large-scale purification processes.
More on ProMetic Mimetic Ligand Adsorbents
ProMetic BioSciences Ltd's ("PBL") synthetic Mimetic Ligand technology is based upon the development and application of small synthetic molecules which have been engineered to specifically capture and purify target proteins. This is achieved using a combination of targeted molecular design and screening of combinatorial ligand libraries. As a consequence of their small size and synthetic origins, Mimetic Ligands offer increased robustness and lower cost compared to biological ligands such as Protein A or immobilized antibodies. This makes Mimetic Ligands ideally suited to biomanufacturing applications, particularly for large-volume applications and processes where there is pressure to reduce manufacturing costs.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montreal (Canada), ProMetic has R&D facilities in the UK, the USA and Canada, manufacturing facilities in the UK and business development activities in the USA, Europe, Asia and in the Middle-East.
About ProMetic BioSciences Ltd
Using its unique and proprietary Mimetic Ligand technology, ProMetic BioSciences Ltd ("PBL") specializes in the development and manufacture of robust affinity separation materials which provide very high levels of purification. This is achieved by use of small chemical affinity ligands designed to bind a target biomolecule specifically and reversibly. In view of their use for the production of therapeutics, ProMetic's affinity products are manufactured to strict quality standards at PBL's GMP-compliant manufacturing facility on the Isle of Man, which completed a pounds sterling 1.5M expansion in 2005. PBL also operates an R&D laboratory located on the Cambridge Science Park, UK.
SOURCE: ProMetic Life Sciences Inc.