Platform Process Development & Scale Up

Platform Process Development & Scale Up

Cobra continues to develop robust and scalable process strategies for viral vector manufacturing and production for AAV, lentiviral vectors and adenoviruses, with media development and optimisation (animal component free), for both adherent and suspension modalities.

We have a standardised approach for the production of Ad5 and have experience with different AAV and lenti processes to support our viral vaccine, immuno-oncology and ATMP gene therapy customer requirements.

To improve the quality and productivity of customers’ viral vector products, Cobra has also developed systems to maximise transfection efficiency and harvest parameters and can optimise multiplicity and point of infection (MOI and POI).

GMP Cell Banking & Viral Seed Stocks

Cobra can provide cell banking and viral seed stock production to support customers’ projects from clinical Phase I, II & III to commercial-scale supply. Working within cGMP manufacturing regulations, we can maintain both Master & Working Cell Banks (MCB & WCB) and Viral Seed Stocks (VSS).

GMP Manufacture

Cobra has been a manufacturer of GMP viral vector products for ATMPs, gene therapies and viral vaccines since 2002 and more recently immuno-oncology therapies.

Our team provides GMP manufacture of viral vector products following Good Manufacturing Practices of production and testing for all viral manufacturing programs to ensure quality products for our customers’ preclinical and clinical trials through to commercial supply.

Processes are clearly defined, controlled and can be qualified to ensure compliance, clear records are made, and any deviations are investigated and documented. We are able to provide a certificate of GMP compliance and, if required, a GMP campaign summary report plus QA review of completed documentation.

Viral Vector Analytical Development & Qualification

Cobra provides analytical support for our customers including analytical method transfer, development, qualification and validation, as well as the development of cell-based potency assays.

Analytical methods for customers’ virus products include reverse phase and ion exchange chromatography, PCR, SDS-PAGE, ELISA, LAL, bioburden, spectrophotometry (UV/visible), fluorimetry, capillary electrophoresis, mass spectrometry, picogreen particle assays, electron microscopy, plaque assays, and TCID assays.

Stability Studies

All viral vector products undergo genetic stability testing, and are assessed according to ICH guidelines for Drug Substance & Drug Product, and through forced degradation and pre-formulation studies.

As part of the Quality Assurance process, viral vector products are tested according to ICH guidelines for Drug Substance & Product. These studies help to determine the effect of external factors on the active component within a customer’s product.

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.

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