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Viral Vectors

As an experienced manufacturer of cGMP viral vector products for gene therapies and vaccines, Cobra’s goal since 2002 has been to deliver customers' virus programs in a cost effective and timely manner for clinical and commercial supply.

Viral Vectors

Platform Process Development & Scale Up

Cobra continues to develop robust and scalable process strategies for viral vector manufacturing and production, with media development and optimisation (animal component free), and adaptation to suspension-based growth.

We have a standardised approach for the production of Ad5 and have experience with different AAV processes to support our viral vaccine and 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).

 Additionally, we can provide GMP cell bank storage and secondary site storage for added security.

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.

Get In Touch

Speak to a member of our expert team and arrange to take a tour of our GMP facilities in the UK and Sweden

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