Our High Quality (HQ) offering adopts features of Cobra’s GMP manufacture, including RNAse free, with a 6 week delivery time. HQ plasmid can be used as an ancillary or starting material for the clinical manufacture of immuno-oncology therapies, for example in AAV, lentiviral vector, and CRISPR products.
Current standard offerings for HQ supply are from 50mg to 500mg of purified plasmid; this can be tailored to meet specific customer requirements. HQ production is performed in a Class 2 segregated laboratory using HQ production cell banks as starting material. The HQ grade plasmids are released with a Certificate of Testing and QA TSE BSE Certification.
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.
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).
We utilize a specific proprietary antibiotic-free maintenance technology, ORT® (Operator Repressor Titration), which provides highly stable, antibiotic-free high copy-number plasmids.
The ORT® technology employs a plasmid-mediated repressor titration to activate a host selectable marker, removing the requirement for a plasmid-borne marker gene.
ORT® can offer numerous advantages when compared with the use of antibiotics and selectable marker genes.