Refinement for a High-Growth Biosimilars Multinational
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Refinement for a High-Growth Biosimilars Multinational
A rapidly expanding biosimilars multinational operating in Asia faced critical supply chain distress, manifesting as escalating backorders despite perceived adequate capacity. This scenario was driven by accelerated market approvals and competitor capacity constraints, highlighting an urgent need for a strategic overhaul of their supply processes. Our engagement focused on transitioning the organization from a reactive, bottlenecked operation to a proactive, strategically-aligned supply engine capable of sustaining high-speed growth.
Initial analysis via Value Stream Mapping (VSM) with technical and manufacturing teams revealed a series of systemic disconnects and operational inefficiencies, demonstrating that perceived capacity was drastically different from realized throughput:
- Mismatched Batch Sizes & Wasted Output: The finishing batch size was 20% smaller than the sterile filling batch. This critical mismatch resulted in 20% of filled product being indefinitely cold-stored and untraceable for finishing, representing significant inventory waste and lost potential revenue.
- Misidentified Bottleneck: Focus was incorrectly placed on the sterile filling operation. In reality, the downstream finishing process was the true bottleneck, running slower than the filling operation and creating a flow mismatch and logjam.
- Delayed Quality & Release: Testing trigger points were delayed (starting with finishing instead of filling completion), adding unnecessary time to the final release cycle and delaying shipments.
- Crippling Quality Hurdles: QA review was exclusively a final-stage process, coinciding with an extremely high level of deviations. This reactive quality approach created unpredictable delays and added significant non-value-added waiting time.
- Poor Asset Utilization: Overall Equipment Effectiveness (OEE) was critically low, ranging from 15% to 20%, indicating massive potential for improvement without major capital expenditure.
In parallel with operational diagnostics, a comprehensive capacity model was developed. This model demonstrated the real, constrained product supply capacity and exposed a critical gap: the current supply plan consistently lagged behind the overall business growth projections, with the deficit projected to worsen year-on-year. This analysis re-calibrated the existing capital expenditure (CAPEX) program, highlighting that current performance levels negated the impact of planned investments.
This dual-pronged diagnostic led to the creation of a ‘North Star’ Value Stream Map, which strategically re-envisioned the supply chain as a flexible, high-flow system:
- Strategic Flow Design: Implementing larger batch sizes and ensuring increasing capacity and capability as the product moved downstream (i.e., finishing capacity greater than filling).
- Time-to-Market Optimization: Eliminating non-value-added waiting times by triggering upstream Quality and implementing a Right First Time (RFT) program to reduce deviations.
A structured, mentored Supply Improvement Programme was implemented, driven by the North Star VSM and capacity analysis. This approach prioritized action into a two-pronged strategy to increase overall throughput and meet demand:
- Short-Term, High-Impact Operational Excellence (Immediate Priority)
These actions focused on leveraging existing assets and fixing flow constraints to rapidly increase output:
- Batch Reconciliation: Implemented a compliant process to consume the 20% cold-stored product and, critically, immediately increased the validated finishing batch size to match the filling output, eliminating the systemic waste.
- Constraint Debottlenecking: Adjusted finishing operations shifts (continuous running, extra weekend shifts) to ensure the finishing capacity exceeded the filling output, reversing the bottleneck.
Efficiency Drives: Implemented continuous OEE monitoring and a Quick Changeover (QCO) program in filling and finishing to drastically reduce changeover times and improve core operational efficiency from the baseline 15-20%.
- Long-Term Strategic Investment Planning (2-Year Priority)
To future-proof supply and align with aggressive growth, a structured approach to capital was implemented:
- Continuous Capacity Foresight: Established a monthly capacity review process that continuously reviewed capacity requirements 18-24 months out. This proactive strategic process ensures that future investment decisions (CAPEX) are triggered well in advance of constraints, guaranteeing long-term alignment between supply capability and business growth.
This strategic refinement successfully transitioned the client’s supply chain from a tactical, bottlenecked operation to a proactive, data-driven, and strategically-aligned system capable of supporting multinational biosimilars growth in the high-demand Asian markets.