Biotechnology Services
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BioManufacturing Support Services
For a company trying to generate material to initiate preclinical toxicology studies or clinical trials, the hurdles associated with biomanufacturing are numerous. Therefore, "working with the end in mind" becomes a critical factor in the eventual success of a development strategy. Once having developed the strategy for process and analytical development, the issues of finding capacity and relevant expertise in the contract manufacturing marketplace remain. We have experience in a broad range of products, including recombinant proteins, monoclonal antibodies, vaccines, gene therapy vectors, natural products and cell therapies.
Internally we can provide:
- Analytical development and validation — addressing the analytical challenges of characterizing your product, setting a specification and demonstrating stability
- Assessing biosafety risks — designing in controls to minimize risk, whether this is to reduce the use of animal derived products or introduce relevant viral removal process steps.
Through collaboration with strategic partners we can provide:
- Help in selection of an appropriate production system — bacteria, yeast, insect cells, mammalian cells
- Cell line development — from cloning to GMP cell banking
- Selection of an appropriate process technology — stirred tank, batch, perfusion, continuous, hollow fibres, roller bottles, cell factories, etc.
- Selection of a Contract Manufacturing Organization (CMO) — how to match your chosen production system and process technology with the CMO having the most relevant experience and available capacity.
See also our links to regulatory agencies.
Please find further Program Management information here. |
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