We provide full analytical support for our customers, including the development of specific assays, assay transfer services, expert product characterisation and DNA sequencing. Support is also available for IND (Investigational New Drug) applications and BLAs (Biological License Applications).
Cleaning validation and raw materials testing is undertaken internally to ensure the highest standards are maintained for all of our customers’ programmes.
Our Quality Assurance (QA) team provide Quality Control (QC) release testing of Drug Substance & Drug Product.
Shipping studies to determine stability for product transportation including variations in temperature, humidity, light and oxygen levels can be undertaken as required.
A typical GMP analytical package would be:
- DNA concentration by absorbance spectroscopy (DNA purity by OD 260/280)
- Purity (Total plasmid) by agarose gel electrophoresis
- Identity by Restriction Digest
- Purity (Supercoiled DNA) by Capillary Electrophoresis
- Residual protein by SDS-PAGE
- Host Cell protein by ELISA
- Residual host cell DNA by QPCR
- Residual host cell RNA by HPLC
- Residual Kanamycin
- Plasmid sequence GMP grade (four-fold coverage)