Categories

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.

More
Assay development, validation and transfer

Assay development, validation and transfer

Analytical methods are fundamental to all aspects of drug development and manufacturing. Accordingly, they require development, validation, and controls just as all other product and process development activities.

More
Nucleic Acid (DNA/RNA) Extraction

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.

More