Stand Alone Services

Cobra has established a range of cell-based and binding-based bioassays to quantify the potency of biomolecules. From bioassay development to cGMP batch-release testing, including method validation, we can advise on the best route for developing an assay for a customers’ product.

The end-point in the bioassay is determined by the mode of action of the customer’s drug.

Cobra’s Bioassay team has broad cell culture and cGMP analytical experience and, depending on the requirement for formal data review, our Quality Assurance department or Quality Control function provides study data audits after the laboratory phase of the work has been completed.

Cobra offers a full range of analytical packages and stand-alone services that are capable of supporting all phases of biopharmaceutical development.

Analytical services include industry standard methods as well as high-end mass spectrometry and physicochemical characterisation according to ICH Q6B. All analytical processes and instruments are maintained at appropriate levels with respect to cGMP and regulatory requirements.

Analytical reference standards can be established for any development phase.

We provide QC release testing of Drug Substance and Drug Product with QA approved Certificate of Analysis for CMC documentation support, including support for setting and justification of Drug Substance and Drug Product specifications. Physicochemical characterisation and comparability according to Q6B can be offered as well as batch release and (re)testing for European markets.

Shipping studies to determine stability for product transportation, including variations in temperature, humidity, light and oxygen levels can be undertaken, as required.

Cobra can provide cell banking of customer's mammalian and microbial products, as well as insect cells, yeast cells and virus products to support Phase I, II & III clinical to commercial scale supply as a stand-alone service. Working within cGMP Manufacturing regulations, we can maintain both Master & Working Cell Banks (MCB & WCB), as well as Master & Working Viral Seed Stocks (MVSS & WVSS).

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

Cobra offers stability testing of customers’ DNA, protein, viral vector and cell products as a stand-alone service. Materials are tested according to ICH guidelines for Drug Substance & Drug Product, with the option of forced degradation (to accelerate the natural degradation process) and stability to support pre-formulation studies.

The effects of different levels of light, heat, humidity and oxygen levels, as well as a broad range of pH levels, are examined. These studies help to determine the effect of external factors on the active component within a customer’s product.

Utilising fully disposable systems and meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures, Cobra has the capability for sterile drug product production of DNA, mammalian and microbial protein, and API parenteral products.

With batch sizes from 1 to 100 litres, we manufacture for clinical through to commercial scale supply with products filled in single-use pre-filled syringes or vials. We also have the capability for freeze drying/lyophilisation of products 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.