Quality Control of Cell Therapeutic Products

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 are applied in line with established protocols. These methods are selected, elaborated, optimized, validated, and routinely applied according to national and international guidelines – depending on the type of the tests, the principles of the Good
Manufacturing Practice, FACT-JACIE International Standards 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, we first 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 Cell Therapeutic Products

Defining cell count and viability with Trypan Blue staining

The cell count as well as the viability of the cells of the starting materials, phase- and end-products deriving from the manufacture of cell therapeutic products is determined with trypan blue staining. Viability is calculated from the ratio of viable and non-viable cells. Trypan blue staining cell count is determined according to Ph. Eur.

Defining leukocyte number with Abacus Junior cell analyzer

Leukocyte count of the starting materials and end products deriving from the manufacture of cell therapeutic products is determined with Abacus Junior cell analyzer.