Over a decade ago, Prometic started developing a sequential purification process in collaboration with the American Red Cross (“ARC”) which aimed to extract and purify multiple commercially viable plasma proteins in high yields from a single source of plasma. The process rapidly allowed for the efficient targeting and extraction of several high-value proteins at yields not seen before by the industry through the use of our Mimetic™ Ligand adsorbent technology. After years of continuous improvement, Prometic successfully developed a robust and scalable manufacturing process; Plasma Protein Purification System (PPPS™).
Today, Prometic’s US based subsidiary Prometic Biotherapeutics Inc.(PBT) in Rockville, Maryland is responsible for the development and commercialization of the plasma purification process. The R&D team at Rockville are constantly perfecting Prometic’s state of the art manufacturing process for the development, manufacturing and commercialization of our best in class plasma-derived therapeutics to address unmet medical conditions in both established and emerging markets.
The PPPS™ sequence has been optimized to give exceptionally high protein recoveries. Due to the nature of the process, some of the rarest and most valuable proteins can be accessed at unprecedented activity levels. The recovery of such proteins allows for the generation of orphan drug opportunities targeting rare diseases with greater efficiency. This gentle purification process also significantly reduces the protein losses compared to the Cohn precipitation method and ultimately leads to lower cost of goods sold, a definitive competitive advantage.
At the heart of our PPPS™ purification process is an application of our core Mimetic™ Ligand bioseparation technologies which are used in a variety of applications from the production and purification of biopharmaceuticals, to the capture and removal of biocontaminants or extraction and recovery of valuable proteins from various sources. This affinity chromatography technique uses an adsorbent comprised of a porous support matrix to which the ligand is attached. The attachment or bonding is performed so that the immobilized ligand is still able to interact with the protein in a specific and reversible manner.
The ligand is normally bound by the protein at a specific site often within a fold of the protein. An affinity separation is then performed by passing the protein solution over the adsorbent, incorporating the ligand, so that the target protein is adsorbed while allowing contaminants (other proteins, lipids, carbohydrates, DNA, pigments, etc.) to pass through without hindrance. The adsorbent is normally contained within a chromatography column. Following adsorption, the adsorbent is washed with buffer to remove residual contaminants and then the bound protein is eluted in pure form.
PPPS™ process overview
Prometic’s state of the art technologies and products are embedded into a successfully scaled-up manufacturing process for the development, manufacturing and commercialization of best in class plasma-derived therapeutics. Prometic’s proprietary and proven affinity adsorbents are incorporated in a downstream, multi-sequential chromatographic process to extract, isolate and purify high value proteins with superior yield and efficiency from what is currently available from the industry. The process also incorporates viral inactivation as well as prion reduction that surpass the industry alcohol based extraction process. The gentle process provides for significantly better yield and economic benefits and is easily adaptable to different protein market needs