Skye Biologics boosts BioECM® allograft production efficiency by 35% with Seal
About Skye Biologics
- Location: El Segundo, Los Angeles
- Industry: Biotechnology -> Regenerative Medicine
- Employees: 51-200
Skye Biologics are at the forefront of advancing regenerative biologic therapies, utilising donor placental tissue to produce a pipeline of therapies aimed at addressing unmet needs across various clinical areas.
Use cases implemented
EBR
QMS
Key metrics
- Efficiency Increase:+50%
- Non-Conformances:-40%
- SOP Review Cycles:2x faster
Testimonials
Loc Huynh
Sr. Director, Quality & Regulatory
Skye Biologics
With Seal, we could quickly transform our existing processes into a digital form. We didn't need to adapt or change them, and even better, it evolves with us as we scale. The support has also been outstanding.
Challenge
Skye Biologics faced significant hurdles with their complex, manual manufacturing process:
- Traceability & Compliance: Ensuring traceability and auditability for FDA compliance and internal analysis was difficult with paper-based systems.
- Efficiency Bottlenecks: Identifying yield issues and rework causes was hindered by reliance on physical documentation, slowing down continuous improvement.
- Data Accessibility: Consolidating records and accessing real-time data across production steps was time-consuming, impacting responsiveness to fluctuating market demand.
Solution
After evaluating multiple vendors, Skye Biologics chose Seal.run for a custom, integrated solution. This digital system unified key operations:
- Document Control
- Training Management
- Audit Management & CAPAs
- Supplier Management
- Inventory & EBR
- Environmental Monitoring & Instrument Integration
Outcomes
Deploying Seal delivered significant improvements and unlocked key insights:
- Increased Productivity: Reduced batch record review time by 50%.
- Enhanced Compliance: Streamlined audit preparation, resulting in a 40% reduction in findings.
- Improved Traceability: Full lot genealogy mapping enabled proactive quality control.
- 35% Efficiency Gain: Achieved across task execution, labelling, reporting, and resource management through data-driven process optimization.
- Reduced Costs: Replaced a dedicated labelling tool with integrated automation, lowering software expenses.