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Biologics drug substance and drug product

Client situation & approach

Our client is Biologics Drug Substance and Drug Product manufactorer in a Global multi-site environment in Europe, USA and Asia. This project was targeted to improve the speed, quality and productivity of the QC functions at individual sites to contribute to a more stable supply of product. Additionally, it focussed on development of a standard capacity planning tool and process to provide visibility of resources at the site and network level. We supported in:

  • At a Network level: A standard best practice visual management model covering daily process control and medium-term performance management; a consistent capacity planning tool and process
  • At a Site level: Levelling, flow & standard work solutions specific to a variety of lab types; Standard best practice approaches to 5S and consumable management

case study Biologics

Results

  • Productivity improvements of the order of 15% released via levelling, flow and standard work
  • Consistent adherence to all lead time targets
  • Accurate projection of required QC resources highlighting likely capacity constraints
  • Implementation of a standard set of global QC KPIs and linking of these to identification and initiation of continuous improvement opportunities
  • Daily lab huddles are driven by a standard visual management system