GLP testing

GLP testing

GLP testing comprises all stages of drug development after drug discovery has been successfully concluded. When a hopeful structure is confirmed as a possible drug candidate, pre-clinical research as the first phase of drug development can begin.

Clinical trial phases I-III are the next stages a candidate drug must consecutively pass. During the whole period of drug development GLP standards are required.

The methods we offer are specialized in DNA/RNA technology and/or cell techniques. Our services are engaged mainly for drug development in the field of gene therapy, biomolecules drugs such as vaccines and proteins.

Nucleic acid DNA/RNA – Biodistribution studies

Nucleic acid DNA/RNA – Biodistribution studies Nucleic acid DNA/RNA – Biodistribution studies

Cell and gene therapy are new branches of pharmaceutical research, which use new types of drugs and strategies. New types of analytical methods are obviously needed. These methods are mostly based on DNA or RNA analysis, which is not surprising, as nucleic acid such as viral vectors, naked DNA (like plasmid, oligonucleotide) or RNA, as active agens is typically used for methods of gene therapy.

Authentication of cell lines

Authentication of cell lines Authentication of cell lines

Authentication of human cell lines is based on DNA finger print analysis, which compares so-called "short tandem repeats" (STR), segments of genomic DNA of the tested cell line, with identical segments of a cell line with a confirmed identity. STR profiles for many of cell lines are published in reviewed databases.

Plasmid tests

Plasmid tests Plasmid tests

Plasmid DNA is currently gaining increasing importance for clinical research applications in gene therapy and genetic vaccination. For direct gene transfer into humans, good manufacturing practice (GMP)-grade plasmid DNA is mandatory.

Nucleic acid (NA) sequence control

Nucleic acid (NA) sequence control Nucleic acid (NA) sequence control

Correct sequence control - check if the sequence is free of mutant variant (insertion, deletion, changes), checking the sequence of interest is a good idea. Sanger sequencing method is a gold standard.

Organism identification

Organism identification Organism identification

If organism identification is needed the analysis of DNA fingerprints is method of choice. For identification so called DNA barcoding method can be used. This method uses a DNA analysis of specific sequences to identify an unknown sample in terms and classify it to particular species.

DNA genotyping

DNA genotyping DNA genotyping

Genotyping is the process of determining differences in the genetic make-up (genotype) of an individual by examining the individual's DNA sequence and comparing it to another individual's sequence or a reference sequence.

Gene quantification (qPCR)

Gene quantification (qPCR) Gene quantification (qPCR)

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.