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GMP testing

GMP testing comprises those stages of drug development when an investigational drug becomes a pharmaceutical drug. ‘A drug prototype’ should be administered to human individuals in clinical trial phases II and III.

If a candidate drug was successfully confirmed in clinical trials and its manufacturing is approved, QM/batch release protocols may include DNA/RNA-based methods and/or cell techniques.

The GMP methods we offer are specialized in DNA/RNA technology and/or cell techniques. They are required for QM/batch release in the field of gene therapy, biomolecules drugs such as vaccines and proteins.

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Residual DNA tests

Much like typical chemical compounds, nucleic acid gene therapy agens, such as plasmids/vectors, viral particles and other, need quality control as well. Mostly it is a detection of unwanted contaminants what is needed. These contaminants originate from production systems where DNA was prepared, either from a cultivation media or as natural contaminants or from the changed original molecule.

Adenovirus detection

Adenoviral vectors serve as oncolytic viruses in many applications and our laboratory has experiences with detection method development, validation and sample analysis. Good example for adenoviral vectors is CGTG-102 (or ONCOS-102), which is in clinical phase now.

Endotoxin detection

This test reveals contamination by bacterial endotoxins (lipolysaccharide), which is a membrane component of gram-negative bacteria. This reaction is the basis of LAL test, used for detection and quantification of bacterial endotoxins.

Mycoplasma detection

Mycoplasma contaminants may be introduced into cell culture and other biological products through master seeds, master cell seed (stock), starting materials of animal origin, and in processing of biological materials during passage and product assembly.

DNA/RNA integrity

Integrity of DNA/RNA is very important test needed according to the Europe pharmacopeia chapter 5.14. Mostly the test can be done as agarose gel electrophoresis or using advanced techniques such as PCR or fragment analysis.

Mycobacterium tuberculosis

Mycobacterium tuberculosis is an obligate aerobic acid resistant rod-shaped bacterium which causes most of the cases of tuberculosis. The term Mycobacterium tuberculosis complex includes closely related bacteria causing the same clinical symptoms – M. tuberculosis, M. bovis, M. africanum, M. microti and M. canetti.