was the first in Ukraine
to produce human plasma-derived medicines
biopharma was among the first in Eastern Europe and in the post-Soviet area to apply the international standards for the quality of viral safety of drugs of human blood plasma. Today, our manufacturing process is an example of a quality standard for other manufacturers.
viral safety — is one of the main tasks in the manufacture of human blood plasma-derived medicines. The plasma we use is imported from the EU countries in particular from Slovakia, Poland and Lithuania, we buy it in the blood centers of Ukraine and also we develop the network of our own plasma centers.
control check — is an obligatory stage of the safety assurance of the drugs. Testing laboratory of the Quality Assurance Department controls the incoming plasma. It is necessary to make sure that it is not infected with HIV, viral hepatitis A, B ,C and parvovirus B19
solvent-detergent treatment is the first stage for inactivation of viral infectious agents in drugs. We inactivate enveloped viruses in drugs by adding compounds that dissolve the lipid envelope of the virus at the molecular level.
The second stage is purification chromatography. We clear the drug from the solvent-detergent compounds and possible remnants of virus particles of enveloped and non-enveloped viruses.
Thus, the patient gets an absolutely safe immunoglobulin solution. In 2005, we were the first in CIS countries to use this method and are still using it successfully.
We have constructed a building with five laboratories. And we make every effort to ensure that each stage of drug manufacturing complies with the requirements of the Good Manufacturing Practice (GMP). The laboratories and quality control systems comply with the European and national standards, confirmed by the Ukrainian regulatory authorities.
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Modernizes the technological processes in the manufacturing of plasma-derived products
Generates new forms of recombinant drugs
Works on technologies of deep cultivation of spore-forming and non-spore-forming probiotic microorganisms
We monitor the product quality. During manufacturing, we monitor the processes of all stages of the life cycle of drugs.