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CPI National Biologics Manufacturing Centre (NBMC)

CPI National Biologics Manufacturing Centre (NBMC). Horizon 2020, Brussels 16/12/2013. SPIRE-1. Core Capability. Fermentation High Throughput Screening Scale-up. Ultrafiltration / Diafiltration Product Purification. Formulation & Fill. Core Capability & Quality by Design.

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CPI National Biologics Manufacturing Centre (NBMC)

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  1. CPINational Biologics Manufacturing Centre (NBMC) Horizon 2020, Brussels 16/12/2013

  2. SPIRE-1

  3. Core Capability • Fermentation • High Throughput Screening • Scale-up • Ultrafiltration / Diafiltration • Product Purification • Formulation & Fill

  4. Core Capability & Quality by Design PROCESS Raw Materials Product ANALYTICS

  5. Core Capability & Quality by Design • Process understanding • - Identify parameters that are critical to product quality • - Identify quality measurements and analyze these parameters • Appropriate instrumentation • Tools for process Monitoring and Control • Continuous Process Improvement • Risk assessment • Data analysis & modelling tools • Multivariate data analysis (MVDA) • Design of Experiments (DoE) • Chemometrics • Soft sensors • Define & predict product yield and quality • Identification of all critical • sources of variability • Early detection & reaction on • variances in process or • quality Data collection, storage and retrieval tools Continuous improvement & knowledge management tools Sample management Instrument and application integration Electronic data exchange Workflows Traceability Raw Materials Product ANALYTICS

  6. What we are looking for • CPI NMBC is looking to join a consortium as a demonstration partner – to demonstrate novel technologies being developed.

  7. Dr Arun Harish+44-7733308260arun.harish@uk-cpi.com

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