GAMASTAN Solution for injection Ref.[10819] Active ingredients: Human normal immunoglobulin G

GAMASTAN is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution of polyvalent human immune globulin for intramuscular administration. GAMASTAN contains no preservative. GAMASTAN is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion-exchange chromatography, nanofiltration and low pH incubation. GAMASTAN consists of 15% to 18% protein at pH of 4.1 to 4.8 in 0.16 to 0.26 M glycine.

When medicinal biological products are administered, infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogens.

In the manufacturing process of GAMASTAN, there are several steps with the capacity for viral inactivation or removal. The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows:

• Caprylate precipitation/depth filtration
• Caprylate incubation
• Depth filtration
• Column chromatography
• Nanofiltration
• Low pH final container incubation

To provide additional assurance of the pathogen safety of the final product, the capacity of the GAMASTAN manufacturing process to remove and/or inactivate viruses has been demonstrated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties.

The combination of all of the above mentioned measures provides the final product with a high margin of safety from the potential risk of transmission of infectious viruses.

The caprylate/chromatography manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD), and Creutzfeldt-Jakob disease (CJD) agents.(15) These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed by the caprylate/chromatography manufacturing process.