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Late Phase Formulations

Case Study: Lifecycle COGS reduction for a US Big Pharma

Customer need

  • The customer had a basket of 6 on-patent products, including API and formulations, approaching expiry
  • The customer wanted a reduction in the COGs for these products to maintain its profitability in the late phase and off-patent stages

What we did?

  • Developed an organizational focus on continuous improvements
    • Trained all employees in Operational excellence and lean projects
    • Trained key employees at Institute of Leadership management
  • Initiated technical process improvements, yield improvements, backward integration in API and alternative sourcing measures

Value to the customer

  • Cost reduction over 2 years for formulations was 9-17% and for APIs was 12-17%
  • Overall price benefit to the customer was 2-9%

Case Study: Developing and manufacturing different formulation type

Customer need

  • Formulation of a new lozenge flavor formulation for existing nicotine smoking cessation product range
  • Pilot batches production for different strengths for US and Europe markets

What we did?

  • Scale-up for initial non-GMP materials in pilot development area followed by production in GMP area for small scale, consumer taste test samples and batches for registration for stability studies and registration
  • Provided inputs to customer on process improvements to prevent friability / increase tablet durability
  • Supported clinical trials and subsequent commercial scale manufacturing through Clinical Trials supply Team and GMP manufacturing facility

Value to the customer

  • Scale-up and manufacture of a different formulation type
  • Improvements in product through process improvements

Case Study: Ensuring reliability of supply

Customer need

  • Maintenance of 99% in-stock position for more than 500 SKUs
  • Assurance of zero quality and regulatory issues

What we did?

  • Ensured alignment of all stakeholders to the expectations and needs of customer through daily meetings
  • Oriented internal supply chain towards customer's needs
  • Established collective responsibility and ownership for actions
  • Provided monthly monitoring of performance and transparent result sharing with the client

Value to the customer

  • Consistent achievement in-stock performance above target for more than 2 years and consequently supply assurance to customer
  • Trusted supplier for the customer - among the top 2 suppliers for Europe