biopharma
was the first in Ukraine
to produce human
blood plasma-derived medicines

Manufacturing process of the human blood plasma-derived drugs

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.

01

input raw materials control

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.

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02

manufacturing
process control

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

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03

viral inactivation of the
plasma-derived products

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.

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Laboratories

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.

The list of our laboratories:

  • Laboratory of chemical control
  • Laboratory of biological control
  • Laboratory of molecular biological methods
  • Analytical laboratory
  • Technological laboratory

the company has its own research center. it is working at
the new technologies:

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 work on ultramodern equipment:

  • Ion Chromatograph and Amino Acid Analyzer Professional 1C Vario by Metrohm
  • Atomic Absorption Spectrometer PinAAcle 900T by PerkinElmer
  • BioTek Multifunctional Fluorometer Cytation 3 with automated digital microscopy

The labratories neither in Ukraine non in CIS countries has the equipment like we

With this equipment, we conduct studies of any level not only for our company, but also for other companies in the industry: research institutes, certification centers

today about 30 new medicines are  being
developed in the center:
  • for use in dermatology
  • drugs acting on the musculoskeletal system
  • anti-inflammatory drugs
  • nasal drops
  • monoclonal antibodies
these drugs have new
therapeutic options and  they are more affordable for patients, because the manufacture is located  in Ukraine

Quality Management System

We monitor the product quality. During manufacturing, we monitor the processes of all stages of the life cycle of drugs.

We control the quality of raw materials:
  • conduct the audit of suppliers
  • conduct test-control of samples of raw materials before procurement
  • check the raw materials for compliance with quality standards and requirements of the registration documents
We guarantee the quality of manufacturing
  • control the processes and conditions for compliance with the requirements of technological regulatory documentation
  • draw up a manufacturing and packaging protocol for each batch of drugs
  • maintain technical and technological documentation according to the GMP (Good Manufacturing Practice) standards
We control the quality of finished products:
  • test all finished products for compliance with the registration dossier (specifications, packaging, and labeling)
  • issue a quality certificate for each lot/batch of finished products
  • issue permission for the distribution from the qualified person
  • monitor the product storage conditions
  • do not pollute the environment
Audit and validation
  • we conduct an internal audit for the strict compliance with the requirements established by the internal and external documentation
  • annually we pass state technical supervision on compliance with ISO series 9001, 13485, 22000, 1401
  • keep the original samples of the released drugs for at least 5 years for arbitration. And conduct programs on complaints and pharmacovigilance
  • all blood products that we produce are subject to an annual control of compliance with the requirements of the European Pharmacopoeia at the leading EU institutes in Germany, etc.

Certifacates