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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.

Regulatory level

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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 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 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.

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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.

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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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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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Adenovirus detection

While the CGTG-102 oncolytic adenovirus has shown efficacy as a single agent against several soft tissue sarcomas, it would also be appealing to use in combination with other regimes, as oncolytic viruses have demonstrated very little overlap in side effects with traditional therapies such as chemotherapy and radiation.

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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.

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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.

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Viral shedding

Oncolytic viruses, which include both naturally occurring wild-type viruses/attenuated viruses and genetically modified viruses, have recently been developed for use in innovative cancer therapies. Genetically modified oncolytic viruses possess the unique ability to replicate conditionally as a unique gene therapy product.

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Southern blot analysis/ restriction endonuclease mapping (RFLP)

Southern blot analysis is one of the oldest methods that is used to analyze DNA. In this method, DNA is first extracted from the sample and quantified by UV spectrometry. Then...

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Nucleic Acid (DNA/RNA) Extraction

Nucleic acid extraction can be tedious and time-consuming. It is the most crucial method used in molecular biology and is the starting point for many downstream processes and product development including diagnostic kits. DNA and RNA can be isolated from any biological material such as living or conserved tissues, cells, virus particles, or other samples for analytical or preparative purposes.

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Regulatory level