GMP & GLP TESTING

We are a GLP and GMP certified EU-located company providing testing specialized in molecular genetic based methods (NAT – nucleic acid tests). Our typical partners are general CROs outsourcing their DNA/RNA-based tests elsewhere. For (pre)clinical trials, we offer tailored analytical methods according to CROs´ demands. We also provide QC for batch release for pharma products as well (GMP testing).

Regarding biological drugs such as gene therapy compounds, biomolecules, vaccines, etc., GENERI BIOTECH covers all stages of development of a new drug – beginning with drug discovery via GLP preclinical testing phase up to later clinical tests.

When the development is successfully concluded, we provide DNA/RNA-based testing for the manufactured pharmaceutical cGMP.

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.

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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.

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Plasmid tests

Plasmid tests Plasmid 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.

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Nucleic acid (DNA) sequence control

Nucleic acid (DNA) sequence control Nucleic acid (DNA) 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.

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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.

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Cell proliferation test / cytotoxicity test

Cell proliferation test / cytotoxicity test Cell proliferation test / cytotoxicity test

Tests may be performed on a wide range of materials: from usual soluble, solid or liquid substances, to preparation of a leach from insoluble substances. The test may be applied in pharmaceutical research, in medical products testing, in cosmetics, and in testing of material compatibility for tissue cultures.

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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.

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Residual DNA tests

Residual DNA tests 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.

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Mycoplasma detection

Mycoplasma detection 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.

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