Virtual Tour of Prometic Life Science's Manufacturing Process

January 4, 2018

Welcome to this virtual tour of Prometic Bioproduction Incorporated, our plasma purification facility located in Laval, Quebec.  You will discover how our industry leading technology is now being used to extract and purify therapeutic proteins from human plasma to provide for the development of best in class products and orphan drugs that target unmet medical conditions and rare diseases.

The plasma used in our purification facility comes exclusively from regulatory approved and recognised US based collection centres. Each donor is registered in a centralised donor database and each plasma sample collected is clearly identified to a specific donor and tested for different viruses and diseases. The collected plasma is then frozen in individual bottles before being shipped to our purification site using a secured and efficient cold chain transportation system. 

Upon arrival at our facility, the frozen  collected plasma is quarantined until all the required documentation and background checks have been performed and completed to satisfaction. The frozen plasma is kept at a constant temperature of -30°c degrees awaiting the start of the production run. At this time we also perform some quality control checks to ensure that we can start the production process in conformance with production requirements and good manufacturing practices (GMP). 

  At this stage of the manufacturing process the appropriate buffer solutions are prepared based upon the specific plasma proteins to be extracted. The buffer solutions are optimised according to each protein specific affinity chromatography requirement to allow for an exceptionally efficient extraction and recuperation process. Once the preliminary manufacturing steps have been completed the plasma thawing process can then begin. An operator manually cuts open each frozen plasma bottle before placing the frozen plasma in a tank where it will thaw.  The temperature and the duration of the thawing process are controlled to make sure the protein properties are conserved an optimum levels. Hundreds of litre batches are prepared pooling together sufficient donors to ensure homogeneity and statistically significant representation of the various protein profiles.

The thawed plasma is now ready for the sequential chromatographic filtration process, the plasma is placed in a portable tank and then connected to a fully automated controller than will feed the first chromatographic column with the appropriate quantity of buffer solution and plasma. The affinity separation process is then performed by passing the filtered plasma solution over the specific protein targeted adsorbent incorporating Prometic's proprietary ligand.  The targeted protein is adsorbed, other proteins pass through without obstruction. Following adsorption, the adsorbent is washed with another appropriate buffer solution to remove residual contaminants and proteins and then the bound protein is eluted in pure form. 

The extraction process is then sequentially repeated using different chromatographic columns and buffer solutions to extract other specific proteins. Prometic's proprietary process allows for the extraction of virtually any proteins including plasminogen, alpha-1 antitrypsin, IVIG, Orphan RX 3, Orphan RX 4 and many more.

When entering the downstream process, each recovered protein is prepared for an additional purification step incorporating viral inactivation and pathogen elimination. Size exclusion filters are used at this step to eliminate any remaining viruses larger than 20 nanometers, a size smaller then even the smallest virus known to man. A cross-flow filtration step is performed to increase the concentration of the desired protein. Lastly, Prometic's proprietary prion removal technology is used to remove prions - a step unique to Prometic which provides for a safer and purer product. A chemical preservative is added to the solution to make the final solution compatible with human usage.

The final bulk active pharmaceutical ingredient is now ready to be shipped for the fill and finish stage where the product is put in vials. Compared to industry standards, Prometic's PPPS technology provides for unpresidented yield, safety and purity of blood plasma derived products. 

For the first time, some of the rarest and most valuable proteins can now be accessed allowing us to pursue orphan drug opportunities- until now unattainable. At last, we can look forward to new hope and much deserved relief for thousands of patients. 

For more information visit our product pipeline page here.

 

 

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