Reliable Partner for Comprehensive Cell Therapy Device Assessment & Validation
Bringing the next generation of cellular therapies to patients involves more than science; it requires reliable equipment, validated reagents, and manufacturing processes that are faster and less expensive. CellSecure Bio partners with biotechnology companies, academic medical centers, and advanced therapy organizations to independently validate cell-processing devices and reagents to meet the rigorous standards of cGMP manufacturing. Ultimately, reaching the goal of high-value and low-cost cellular therapy products for patients.
Our comprehensive approach includes OQ/PQ, compatibility assessment, and device readiness for cell therapy manufacturing. Verified data-driven reports confirm that the equipment and reagents are suitable for clinical cell therapy manufacturing and will perform reliably in accordance with established specifications.
Clients retain full ownership of all data and records generated throughout the process.
Independent Assessment & Validation
Comprehensive, unbiased third-party assessment and validation services for evaluating new equipment and devices are reliable, safe, and effective when used in cellular therapy manufacturing.
Our independent testing and validation assess equipment performance by measuring cell viability, consistency, recovery, and functionality under conditions that simulate real-world cGMP manufacturing across multiple runs.
Comprehensive, unbiased third-party assessment and validation services for evaluating new equipment and devices are reliable, safe, and effective when used in cellular therapy manufacturing.
Our independent testing and validation assess equipment performance by measuring cell viability, consistency, recovery, and functionality under conditions that simulate real-world cGMP manufacturing across multiple runs.
Key Benefits:
• Performance benchmarking against industry standards
• Risk assessment and failure mode analysis
• Scalability and reproducibility validation
• Detailed reports supporting regulatory submissions
• Compatibility studies
Key Benefits:
• Lot-to-lot consistency testing
• Compatibility studies with specific cell types and processes
• Impurity profiling and safety assessments
• Documentation package for IND/BLA support
Services Include:
• Potency, identity, purity, and safety assays
• Method qualification and validation per ICH and FDA guidelines
• Transfer and training for in-house implementation
Obtain high-quality primary cells specifically for validation and testing purposes. Custom isolation services from multiple tissue sources using optimized, reproducible protocols.
Applications:
• Instrument and reagent validation studies
• Process optimization and comparability studies
• Control material generation
Understand the customer’s product, goals, and specific requirements.
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Develop a customized validation protocol.
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Perform testing duplicating real scenarios under controlled conditions to yield actionable data.
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Deliver comprehensive, actionable data packages.
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Ongoing consultation and follow-up testing, as needed.
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Understand the customer’s product, goals, and specific requirements.
Develop a customized validation protocol.
Perform testing duplicating real scenarios under controlled conditions to yield actionable data.
Deliver comprehensive, actionable data packages.
Ongoing consultation and follow-up testing, as needed.
Ensure your devices and reagents meet cGMP standards. Request a Validation Assessment
