Overview
SaniSure is a global leader in designing, developing, and manufacturing single-use solutions for the bioprocessing and advanced therapeutics industries. The company resulted from the merger of six market-leading companies (Cellon, Silicone Altimex, TBL Performance Plastics, Sani-Tech West, GL Engineering, and Medical Elastomer Development) to create a comprehensive single-use solution provider. SaniSure operates five manufacturing facilities globally with extensive capabilities for custom product fabrication.
Core Products and Solutions
Single-Use Components:
- Custom and off-the-shelf assemblies
- Sterile bottles and containers
- Tubing and connectors
- Fittings and connectors
- Mixing and agitation systems
- Filling and transfer systems
Engineered Systems:
- Aseptic transfer systems
- Mixing and integration solutions
- Integrated storage systems
- Customized complete assemblies
Key Capabilities
- In-House Manufacturing: Five manufacturing facilities across US and Europe
- Fully Characterized Components: All components thoroughly tested and documented
- Custom Fabrication: Extensive capability for tailored product development
- Sterile Systems: Engineered for sterility assurance and contamination prevention
- Quality Assurance: Meets stringent bioprocess requirements
Industry Applications
- Biopharmaceutical Manufacturing: Monoclonal antibodies, recombinant proteins, biosimilars
- Vaccine Manufacturing: Single-use systems for vaccine production and filling
- Cell and Gene Therapy: Specialized solutions for autologous and allogeneic therapies
- Advanced Therapeutics: Emerging therapy manufacturing requirements
- Research and Development: Pilot-scale and process development applications
Strategic Advantages
- Reduced Contamination Risk: Single-use eliminates cross-contamination risk
- Regulatory Compliance: Designed to meet FDA, EMA, and other regulatory requirements
- Rapid Implementation: Single-use systems accelerate time to market
- Scalability: Systems designed for seamless scale-up from development to production
- Cost Efficiency: Eliminates cleaning validation and related costs
Market Presence
Global operations with manufacturing facilities in the United States and Europe, serving pharmaceutical, biotech, and advanced therapy companies worldwide.
Future Vision
SaniSure continues to innovate in single-use technology, developing advanced solutions for emerging manufacturing processes and new therapeutic modalities including gene therapy, cell therapy, and next-generation biologics.
Last updated: 2026-02-14