The Experimental Production Division of Advanced Plasma Processing at the National Medical Research Center for Hematology (NMRC for Hematology) of the Russian Ministry of Health has received an extension of its license from the Ministry of Industry and Trade. This license permits the production of liquid forms of immunobiological drugs and blood products in accordance with the Eurasian Economic Union (EAEU) Good Manufacturing Practice (GMP) rules.
The license extension will enable the expansion of the line of drugs produced from blood plasma. In addition to the production of “Agemfil A” (Blood Coagulation Factor VIII), this will allow for the transition to the clinical trial stage of drugs such as “Human Normal Immunoglobulin” and “Human Albumin” to assess their safety and efficacy before registration and market launch.
“For several years, the NMRC for Hematology has been developing the technology for chromatographic extraction from blood plasma, purification, viral inactivation, and formulation of these drugs (‘Human Normal Immunoglobulin’ and ‘Human Albumin’),” says Evgeniy Golubev, Head of the Experimental Production Division of Advanced Plasma Processing. “This was followed by the validation of technological processes, development of control methods, and study of the stability of the drugs and their intermediates. A preclinical study was conducted to identify possible side effects, which confirmed the safety of the immunoglobulin and albumin drugs for the possibility of conducting clinical trials in the future.”
Expanding the range of drugs derived from blood plasma will help reduce their cost. This is because expensive donor plasma contains dozens of vital proteins in low concentrations. Extracting only one protein (drug) means other valuable components are not utilized. By increasing the number of proteins extracted from a single plasma batch, immunoglobulin, albumin, and blood clotting factors can be isolated sequentially.
Human Normal Immunoglobulin, by replenishing antibody deficiency, reduces the risk of infections in patients with primary and secondary immunodeficiency. Human Albumin is used to restore and maintain blood volume in the body after significant blood loss, burns, and other conditions.
Previously on this topic:
The NMRC for Hematology Receives EAEU GMP Certificate and Expands the Line of the Drug “Agemfil A”
Industrial Production of the Drug “Agemfil A” in New Dosages Has Begun
NMRC for hematology is preparing for the production and release into civil circulation of drugs for the treatment of hemophilia
