Prometic Mimetic Ligand™ Adsorbent Successfully Implemented In Large-Scale Biomanufacturing Process
News Sep 20, 2007
ProMetic Life Sciences Inc. has announced 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.