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Hyperimmunes

Importance

            Hyper immune globulins are similar to intravenous immunoglobulin (IVIG) except that it is prepared from the plasma of donors with high titers of antibody against a specific organism or antigen in this case it is obtained from recovered patients that have developed immunity to COVID-19.

            In our process plasma is treated with double virus inactivation (solvent-detergent and Nano filtration) for safety. Some agents against which hyper immune globulins are available include hepatitis B, rabies, tetanus toxin, varicella-zoster, etc. Administration of hyper immune globulin provides "passive" immunity to the patient against an agent. This is in contrast to vaccines that provide "active" immunity. However, vaccines take much longer to achieve that purpose while hyper immune globulin provides instant "passive" short-lived immunity. Currently there are no vaccines, monoclonal antibodies (mAbs), or drugs available for  COVID-19, although many are in rapid development and some may be available in a short time. One option argues that human convalescent serum is an option for prevention and treatment of COVID-19 disease that could be rapidly available when there are sufficient numbers of people who have recovered and can donate immunoglobulin-containing plasma. However, a purified IgG from convalescent serum would be more pure and standardized without needed blood type or associated issues with administration of plasma.  Hyper immunes can be administrated prior and during intensive care treatment in patients which need added anti-body protection. This method is safer and more robust than using plasma. The volume of a plasma treatment is over 200mL while the treatment of a purified immunoglobulin is 2 to 10mL

We can supply a fully turn key process.

Some of the general characteristics of the process:

1. 10 or more liters of plasma can be processed in 8 hours or less.

2. Incorporates  single step chromatography and robust and renown virus inactivation processes: Solvent detergent and Nano filtration.

3. The final product does not have to match the blood type of the recipient as required by using convalescent plasma treatment.

4. The process requires only one or two persons.

5. We utilize pre sterilized disposable technology, no need to sanitize tanks or containers.

6. The process purifies the gamma globulin portion of plasma to generate a high purity and yield. Purity 98% and yield over 80% IgG. Without dimmers of IgA

7. Plasma transfusion has more associated complications than IgG therapy.

8. Total footprint of process area is less than 100sq meters.

9. The time to setup the process equipment takes less than 5 days.

10. The final product can be tittered as a concentrate of immunoglobulin’s while plasma therapy cannot (each plasma donor has a different concentration of anti-Covid-19 immunoglobulin’s)