DNA

Cobra provides cloning services for any gene from any source and provides vector development including plasmid and strain construction and development, along with the DH1 strain available in-house.

We utilise a specific proprietary antibiotic-free maintenance technology, ORT® (Operator-Repressor Titration), which provides highly stable, antibiotic-free high copy-number plasmids.

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:

• Appearance
• pH
• 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
• Endotoxin
• Residual protein by SDS-PAGE
• Host Cell protein by ELISA
• Residual host cell DNA by QPCR
• Residual host cell RNA by HPLC
• Residual Kanamycin
• Bioburden
• Plasmid sequence GMP grade (four-fold coverage)

Cobra manufactures non-GMP plasmid DNA plus  High Quality (HQ) and fully GMP plasmid DNA which follows Good Manufacturing Practices of production and testing including DNA sequencing to ensure the release of quality products for our customers’ preclinical and clinical trials through to commercial supply.

All manufacturing processes are defined and controlled to ensure compliance. Clear records are made and any deviations are investigated and documented. 

Operating efficiently and consistently through our platform DNA process, Cobra’s DNA programs meet manufacturing standards worldwide, with full regulatory support from our Quality Assurance (QA) team. We are able to provide a certificate of GMP compliance and GMP campaign summary report with QA review of completed documentation.

Since 1998 Cobra has also been providing cell banking and full GMP certification to support customers’ projects. Working within GMP manufacturing regulations, we can supply both Master & Working Cell Banks (MCB & WCB). Additionally, we can provide GMP cell bank storage and secondary site storage for added security.

As part of the Quality Assurance process, DNA plasmid stability is tested according to ICH guidelines for Drug Substance and Drug Product. These studies help to determine the effect of external factors on the active component within a customer’s product and are critical for regulators.

The effects of different levels of light, heat, humidity and oxygen levels, as well as a broad range of pH levels, are examined.

Forced degradation studies, to accelerate the natural degradation process, are also undertaken to determine the effect on the product.