Compliance with international pharmacopoeias
Pharmaceutical preparations produced by genetic engineering methods can be contaminated with DNA derived from the host cells. Before obtaining a decision allowing the admission to the market of a recombinant protein preparation, the manufacturer must demonstrate that the content of residual DNA in the preparation does not exceed the acceptable standards.
The Labtech team has experience in developing methods for determining the level of DNA contamination (both genomic and plasmid DNA) from host cells in pharmaceutical preparations.
We have developed methods for the determination of DNA contamination in recombinant human insulin and in the recombinant vaccine haemagglutinin of the H5N1 influenza virus.
We offer the development of a method for determining residual host DNA in recombinant protein preparations tailored to the requirements of a given project. The scope of the study includes preparation of the preparation for analysis, design and execution of real-time PCR reactions allowing for specific detection and determination of the level of DNA contamination from host cells (genomic and plasmid DNA).
Markings are made using the LightCycler® 480 II apparatus with IQ / OQ documentation and current certificates.
Completion date: to be agreed.