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Proteins

Cobra produced its first protein product in 1995 and since then has offered a broad range of integrated and stand-alone development and cGMP services for mammalian derived therapeutic proteins, biosimilars, monoclonal antibodies and antibody fragments (FABs) for preclinical, Phase I to III clinical, and commercial supply.

Cell Line Development (maxXpress)

Accelerating production of recombinant proteins, mAbs and biosimilars.

We provide cloning services for any gene from any source, utilising our maxXpress service, which uses UCOE technology to enable rapid production of monoclonal antibodies (mAbs), recombinant proteins and biosimilars while ensuring efficient, stable expression.

The ambr™ system is adopted for optimised cell culture development in mini bioreactors, reducing development time by 80% compared with conventional methods.

Apart from our platform expression system (UCOE and CHO-S) we have worked with different expression systems and cell lines provided by our customers, such as:

  • CHO-K1
  • CHO-S
  • HEK293
  • Hybridomas
  • PER.C6
  • Sp2/0-Ag-14
Proteins

Platform Process Development & Scale Up

Improving process yields of recombinant proteins, monoclonal antibodies (mAbs) and biosimilars.

Cobra continues to develop robust and scalable processes for protein expression, with media development and optimisation (animal component free), and the maximisation of harvest parameters, improving both the quality and productivity of our customer's antibody products.

Our efficient platform process for antibody production and purification also reduces development time and, when combined with our maxXpress service, provides significantly improved yields.

GMP Cell Banking

Cobra can provide cell banking and full GMP certification to support customers’ antibody projects.  Working within cGMP manufacturing regulations, we can supply and maintain both Master & Working Cell Banks (MCB & WCB).

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

cGMP Manufacture

Cobra provides GMP manufacture of mammalian derived therapeutic proteins (monoclonal antibodies as well as other recombinant proteins) and biosimilars, following Good Manufacturing Practices of production and testing to ensure quality products for customers’ preclinical and clinical trials through to commercial supply.

Processes are clearly defined, controlled and validated to ensure compliance, clear records are kept, and any deviations are investigated and documented. We are able to provide a certificate of cGMP compliance and GMP campaign summary report with QA review of completed documentation.

In 1995 we manufactured our first protein, a monoclonal antibody (mAb) to target stem cells, and since then we have manufactured a diverse range of proteins and biosimilars, including vaccines for malaria and meningitis, and disease-modifying protein therapies for arthritis, conjunctivitis and hepatitis B and C.

Fill Finish

Pre-clinical, clinical and commercial scale aseptic secondary manufacturing.

Our comprehensive service offering includes the capability for producing sterile drug products, utilising full disposable systems and meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.

With batch sizes from 1 to 100 litres, we manufacture for clinical through to commercial scale supply, with products filled in single-use syringes (0.5 - 10.0ml) or vials (2.0 – 100.0ml), with the option of freeze drying/lyophilisation, if required.

All batch records are fully traceable under QA observation with QP review and issue of cGMP Certificate of Compliance, and regulatory documents are reviewed as required to support product release to clinic. Primary labelling of drug product vials for human clinical centres, secondary packaging and labelling of vials for dispatch to clinical centres, and tertiary and transport labelling and packaging can also be arranged according to regulatory requirements.

Stability Studies

Products are tested according to ICH guidelines for Drug Substance & Drug Product, and through forced degradation and pre-formulation studies.

As part of the Quality Assurance process, protein 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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