Process Development and R&D
The Process Development and R&D team offers expertise and services to support the development of ATMP from early R&D stages to GMP-readiness.
Our mission:
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Your success: fully committed to helping you to achieve your aims in the most efficient way and to the highest quality. Your success is our success.
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Your satisfaction: determined to provide you with the best end-to-end customer experience through tailored support, clear communication and the personal touch. We are on your side.
Our team:
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A highly competent, friendly and passionate group of scientists, with a broad range of scientific and technical skills to help you develop your cell therapy product
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86% hold a Master degree or above, 40% hold a PhD
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Expertise in a broad range of disciplines including:
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Cell and gene therapy - 25 years of experience in cell therapy
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Cellular, molecular and developmental biology (Including iPSC)
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Immunology
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Statistical analysis
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QbD and PAT principles
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Project management
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Scientific writing
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Our services
From concept to bench top, our team can help you with:
R&D:
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Consultancy, strategic advice, project evaluation, gap analysis
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In vitro proof of concept, mode of action, feasibility studies
From bench top to clinical manufacturing, our team can help you with:
Analytical development:
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Product characterisation, phenotyping and functional assays, cell-based assay, biochemical assays
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Assay design, development and optimisation, GMP-readiness, technical transfers to Quality Control
Process development:
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Process design, development, optimisation and monitoring, GMP-readiness, technical transfers to Production
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Process and product characterisation, identification of CQA, CMA and CPP, scale-up, scale-out, automation