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. The same holds true if the drug substance contains a genetically modified cell, for example chimeric antigen receptor (CAR) T cells.
In Generi Biotech, we offer testing of the plasmids for residual host cell DNA, which is considered an unacceptable impurity in an intermediate or final gene therapy product.
We can also test your artificial vectors and viral vaccines for the presence of wild type virus, which is also a contaminant and can pose a serious safety threat.
Our typical GMP package also includes:
gb Easy PCR Master Mix gb Easy PCR Master Mix consists of hot-start Taq DNA polymerase, reaction buffer, dNTP and MgCl2. The Taq polymerase is chemically modified DNA polymerase from Thermus aquaticus. This polymerase is completely inactive at room temperature but it is rapidly activated during the initial denaturation step of PCR. The product falls into a group of TaqMan Real-Time PCR Master Mixes to provide probe-based qPCR.
Why choose alternative dyes instead of "genuine" dyes? First, they are cheaper, and second, they can give the same results. Another reason is that the number of suppliers who can provide modified oligonucleotides is restricted - only a patent or a licence owner is usually allowed to produce them.
Background Probiotics are defined as live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. For instance, probiotics can be used in the treatment and prevention of infections and chronic inflammatory disorders of the gastrointestinal tract. Due to their health attributes, probiotics generate considerable interest in the area of functional
The avermectins compose a class of polycyclic lactones that are used to treat parasitic worms and insect pests. They are naturally occurring compounds generated in a fermentation process by a soil actinomycete Streptomyces avermitilis.
Biodistribution (BD) studies are critical components when assessing the preclinical safety evaluation of cell and gene therapy molecules. BD analysis is generally conducted at the molecular level using a methodology that provides high sensitivity.
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