Client Challenge

A biotechnology client developing a promising glioblastoma therapy in Phase 1 clinical trials approached KamTek to provide end-to-end storage and distribution support. Their primary concern was ensuring consistent, on-time delivery of drug product at -20°C to multiple clinical sites and hospitals to enable smooth patient enrollment. The solution required precise temperature control, real-time tracking, regulatory compliance, and full inventory traceability.

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KamTek's Approach

KamTek leveraged its -20°C cold room for product storage and conducted extensive research to identify the best solution for reliable cold chain transport. After evaluating multiple providers, KamTek selected the Credo Cube^® containers by Peli Biothermal, known for their ability to maintain sub-zero temperatures for extended durations.

To validate the solution, KamTek conducted extensive test runs and real-world simulations, equipping containers with redundant temperature data loggers. Testing confirmed that the Credo Cube could maintain-20°C for over 5 days, meeting the client’s requirements for both temperature stability and shipment duration.

KamTek also implemented a 21 CFR Part 11–compliant inventory management system to track product inventory, shipment history, and temperature records in a secure, auditable manner. This ensured end-to-end traceability, regulatory compliance, and real-time visibility for the client

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Implementation and Execution

To ensure timeliness, security, and cost-effectiveness, KamTek used a hand-delivery model with reusable Credo Cube containers and reusable data loggers, minimizing delays and improving accountability. A robust contingency plan with backup containers and spare data loggers ensured uninterrupted supply.

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Proven Results

To date, KamTek has successfully shipped over 3,000 vials to various clinical sites, leading to administration in more than 60 patients. Early trial data indicates minimal toxicity and encouraging signs of efficacy, highlighting the critical role of a reliable supply chain in the success of the trial.

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Outcome

• Consistently delivered drug products on time and within strict -20°C conditions.
• Maintained CFR Part11–compliant inventory and temperature records for full regulatory traceability.
• Supported over 60 patients receiving therapy with minimal toxicity and promising efficacy signals.
• Provided a secure, auditable, and efficient delivery model that met the critical needs of a Phase 1 clinical trial.

KamTek’s commitment to treating every client’s product as its own ensured reliable cold chain logistics, regulatory compliance, and patient-focused execution.

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