The Quality Control Laboratory of the Cell Therapy Center Ltd. performs quality control tests of starting materials, phase products, end-products, clinical samples and excipients deriving from the manufacture of vaccines and cell therapeutic products as well as the quality control of the manufacturing environment.
Our test methods are optimized, validated, and applied in line with established protocols. These methods are selected, elaborated, optimized, validated, and routinely applied in accordance with national and international guidelines – primarily the principles of the current Good Manufacturing
Practice and the MSZ EN ISO/IEC 17025 standard.
Apart from methods elaborated according to these documents and other references, several tests are developed on the basis of the protocols of our laboratory. Our highly-qualified professionals continuously monitor the adequacy of our laboratory activity by means of self inspections, auditing suppliers, controlling and certifying the applied materials and equipment, and by examining control materials.
Our laboratory applies certified materials, chemicals, reagents, qualified machines and equipment, and calibrated metering devices. The operational parameters of our equipment are continuously monitored.
In case of receiving an order on our activities described in our website, first we send information to our clients on sampling and sample sending with regard to the given test , which contains method-specific parameters (e.g. lowest test limit, sample types, etc.). Upon request and following negotiations, our laboratory elaborates and validates other tests, or develops methods for new sample types.
Quality control of vaccines
– Influenza HA RT-PCR test
The test is aimed at defining influenza virus strain types (A/H1(N1), A/H3(N2), B) by identifying the gene encoding the haemagglutinin protein.
In the method, first cDNA molecule is produced by reverse transcription from the isolated RNA sample then the nucleic acid of the influenza virus is amplified by polymerase chain reaction. The haemagglutinin gene is amplified by specific primers. Amplification is comprised of two steps, which increases reaction specificity and also the PCR product volume. In the course of detection, the PCR products are visualized and the molecule weight thereof is defined by means of agarose gel electrophoresis with regard to molecule weight markers.
– Hemagglutinin titer (HA) test
When performing the haemagglutinin titer test, the influenza virus concentration in the test samples is defined based on the haemagglutination ability of chicken erythrocytes. Test results are defined in haemagglutinin units (HAU).