cpi national biologics manufacturing centre (nbmc)
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
© CPI 2013. All rights reserved.
CPINational Biologics
Manufacturing Centre (NBMC)
Horizon 2020, Brussels16/12/2013
SPIRE-1
Core Capability
Fermentation High Throughput
Screening Scale-up
Ultrafiltration / Diafiltration
Product Purification Formulation & Fill
Core Capability & Quality by Design
ANALYTICS
Raw Materials
Product
PROCESS
Core Capability & Quality by Design
ANALYTICS
Raw Materials
Product
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 criticalsources of variability
Early detection & reaction onvariances in process orquality
Data collection, storage and retrieval tools
Continuous improvement & knowledge management tools
Sample management
Instrument and application integration
Electronic data exchange
Workflows
Traceability
What we are looking for
• CPI NMBC is looking to join a consortium as a demonstration partner – to demonstrate novel technologies being developed.
