Biologics Drug Substance and Drug Product


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.

Solutions Deployed

  • 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

Biologics Drug Substance and Drug Product - BSM


  • 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 driven by a standard visual management system

Client Environment

Biologics Drug Substance and Drug Product


Global multi-site program in Europe, USA and Asia