Case Study Summary
Sarepta Therapeutics, a pharmaceutical company specializing in RNA and gene therapy manufacturing, operates in one of the most complex and regulated supply chain environments in the industry. The company faced significant operational challenges with manual planning processes, lack of systematic planning logic, and excessive data collection requirements that diverted key personnel from strategic analysis and decision-making.
Sarepta addressed these challenges by implementing Eyelit Technologies’ advanced Supply Chain Planning solution, which provided comprehensive automation and optimization capabilities specifically designed for pharmaceutical manufacturing. The solution delivered streamlined processes, extended planning horizons, detailed scheduling capabilities, and sophisticated tracking systems to ensure compliance with pharmaceutical quality standards.
The Challenge
Overcoming the challenges and intricate requirements of pharmaceutical supply chains presented Sarepta with several key operational obstacles that needed to be addressed:
Key Goals Include:
- Streamline a currently manual planning process
- Systemize key planning logic for long term persistence and backup
- Minimize data collection and manual transformation to allow key users to focus on plan analysis and what if scenarios
Process Complexity
SCP Modeling needed to cover two key process flows:
- RNA – The primary focus area with detailed design and data collection
- Gene Therapy – An emerging area that required future consideration and development
The Solution
RNA Process Flow
The Supply Chain Planning (SCP) solution covers the following comprehensive process flow:
- Raw Materials including Alcohols (grams)
- Subunits (grams)
- API / DS (Drug Substitute) (grams) – Key area where detailed capacity is modeled
- DP (Drug Product) (convert from grams to vials)
- Finished Good (vials)
The process flow follows this sequence: Raw Materials (g) → Subunits (g) → API / DS (g) → DP (vials) → FG (vials)
Key Functions Provided
Eyelit Technologies’ solution delivered comprehensive capabilities specifically designed for pharmaceutical manufacturing:
Planning and Scheduling Capabilities
- 6-8 year planning horizon where the typical supply chain spans 1-2 years
- Detailed (white box) scheduling of reactors for drug product with contract manufacturing (gray box) for subunits, drug substance, and packaging
- Large setup modeling for detailed scheduling and pseudo sequence including setups that span weeks
- Lot / vial tracking for complete traceability
- Contract manufacturing optimization using sourcing constraints
Quality and Compliance Features
- Aggregate safety stock modeling (one period of cover for a part across multiple regions)
- Region restriction management including varying region expiration (some vials “proven” for certain regions but restricted for others)
- Receiving dock (min / max) time for customs modeling
- Quarantine (min / max) time for post-manufacturing testing requirements
- Batch size modeling for optimal production planning
- Manufacturing / expiry date tracking ensuring “expired” parts are not used to satisfy demand
Results and Benefits
The implementation of Eyelit Technologies’ pharmaceutical supply chain planning solution provided Sarepta with:
- Streamlined Operations: Elimination of manual planning processes and implementation of automated, systematic approaches
- Extended Planning Horizon: Capability to plan 6-8 years ahead compared to typical 1-2 year pharmaceutical supply chains
- Enhanced Visibility: Comprehensive tracking of lots, vials, and expiry dates throughout the supply chain
- Regulatory Compliance: Built-in quarantine and testing time modeling to ensure pharmaceutical quality standards
- Optimized Manufacturing: Detailed reactor scheduling and contract manufacturing optimization
- Risk Management: Aggregate safety stock modeling and region-specific restrictions to ensure supply continuity
- Data-Driven Decisions: Reduced manual data collection allowing key users to focus on analysis and strategic planning