For information on our biotechnology capability, please contact Stephen Taylor.
Biotechnology
Our expertise in biotechnology extends beyond the design, engineering, project/construction management and validation of new and upgraded facilities. We understand the technologies and can help in providing a wide range of operational solutions.
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We know that advances in bioprocessing, particularly in drug discovery, are generating exciting new products of increasing complexity. We also recognise that the regulatory, initial capital outlay and manufacturing cost for taking these through to commercial reality can be prohibitive if not carefully defined, analysed and managed.
We are helping biotech companies, large and small, in responding to this challenge by understanding and controlling the cost of manufacture and capital investment and their interrelation (Cost of Goods) as well as applying proven risk based regulatory techniques from early on in clinical development through to full scale manufacture.
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Photo courtesy of Stedim
Whether you are designing a new facility, renovating an existing one or working out the details for contract manufacturing of your product, our team have the experience and resources to assist you in the most cost-effective, flexible and safe solutions.
At all stages from research to commercial realisation and full scale manufacture we provide a full multi-disciplined service including consultancy, design, engineering, project management and validation capability.
We have strong capabilities in all biotechnology platforms including:
- mammalian
- microbial
- viral
- transgenic
- yeast expression systems.
Our process capability includes:
- inoculation preparation
- fermentation
- biocatalysis
- Chromatography
- centrifugation
- filtration
- final formulation
- aseptic filling
- freeze drying
- clean utilities
- contained clean room technology
- equipment selection
- batch scheduling
- process simulation
- cost of goods analysis
- commissioning
- validation.
Our unique and unrivalled experience includes:
- data sets covering real operations in the USA and Europe
- services ranging from consultancy advice to full EPCMV projects of over £50M capital value
- new and upgraded facilities for biotech and contract manufacturing companies
- debottlenecking and efficiency improvements using manufacturing simulation and cost of goods models.
It is this type of insight and experience that can mean the difference between failure and success to many of our clients.
See our project experience.
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