Biopharmaceuticals and Regenerative Medicine
Concept Design
  • Process and facility design to match User Requirement Brief
  • Design in operability, constructability, maintainability and GMP
  • Options explored with users and stakeholders
  • Agreed option developed and costed
  • GMP review and risk analysis
Capital Project
  • Process and analytical design
  • Process specification and procurement
  • Facility and HVAC specification
  • Qualification management (VMP, DQ, IQ, OQ)
  • Contractor selection
  • Project and construction management
Business Case
  • Fit with strategic objectives
  • Manufacturing options
  • Return on investment and sensitivity analysis
User Requirement Brief
  • Discussions and involvement with each stakeholder
  • Align with project and strategic objectives
  • Obtain sign off

Start-Up and Operations

  • Capacity planning and optimisation
  • Operational excellence
  • Programme management
  • Process & analytical development and transfer to manufacture
  • Quality management system
  • Manufacturing organisation and recruitment
  • Licensing strategy, site master file and license application
  • Production scheduling
  • Product release (QP)