Immunorel Caution For Usage

Product Safety: The manufacturing process for Normal Immunoglobulin (ImmunoRel) uses plasma collected from approved blood banks where the donors are screened for their history as per guidelines laid down by the regulatory authorities. Their blood is screened for the mandatory infectious diseases. These are repeat donors whose samples are quarantined and re-tested. Only on being declared negative the plasma is used for processing.
After manufacturing, the product is tested by suitable methods to show negative from viruses like HIV, HBV, HCV, Parvovirus and HAV. The manufacturing procedure incorporates the well-known time tested and proven method of Solvent Detergent Technology, which inactivates lipid-coated viruses. Multiple steps have been employed to assure product safety hence there is a very remote probability that unknown infectious agents may be present in these products like lesser known viruses and theoretical CJD (Creutzfeldt Jakob disease).
Validation studies were carried out to validate the efficiency of the manufacturing process to remove and/or inactivate viruses. The manufacturing processes with the incorporated viral inactivation procedures have been validated as per recommendations and guidelines provided by the committee for proprietary medicinal products (CPMP guidelines).
These studies were conducted using starting intermediate samples spiked with model viruses to represent the worst-case conditions. Appropriate samples were drawn for viral titer determinations from manufacturing intermediates keeping in mind the process parameters; characterizations and final product quality meet the regulatory requirement.