Quality and microbiological controls

The Quality Control is the part of the GMP related to the sampling and testing procedures that ensure that the necessary and relevant tests have been carried out and that the product is released, for the use for which it is intended, only after its quality has been verified.

The Quality Control Laboratory performs the tests in process and the tests necessary to release the cell drugs produced at FaBioCell and can also perform service activities for other Cell Factories.
FaBioCell is currently able to perform the following tests, in accordance with the European Pharmacopoeia (EP), where available, or validated according to a specific protocol:

• Sterility test - direct inoculation (in agreement with European Pharmacopoeia (EP));
• Determination of Endotoxin - LAL test (in agreement with EP);
• Determination of Mycoplasma-indicator cells method and PCR method (according to EP);
• Cell viability (in agreement with EP);
• Test to evaluate: cell growth, drug resistance, functionality, cytotoxicity;
• Verification of cell phenotype by flow cytometry.