Cold Chain Logistics Solutions Company

Our client is a premier provider of cold chain logistic solutions for biopharma, IVF, and animal health organizations globally.

The client recently expanded their range of supply chain services offered to the cell and gene therapy industry with two new site locations in New Jersey and Texas. The new facilities will serve as a commercial partner for their own clients with new state-of-the-art global supply chain centers. This will provide the latest technologies and employ experienced staff to ensure the highest quality and compliant services to support clinical and commercial advanced therapy programs.

NEXA’s Validation team executed over 400 unique tasks to complete 38 qualification packages. This was accomplished on a fast-track schedule to ensure we hit the “go live” date for each site.

NEXA’s team of onsite engineers and support staff provided validation services for their new site locations, which involved the validation of:

• (20) -80oC Freezers
• (4) Cryocarts
• (14) LN2 Tanks

NEXA’s equipment testing included Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).

Our client is now audit ready to verify that the equipment was installed, operates, and performs to the predefined specifications of its intended use. This ensures they are prepared to serve their clients’ cold storage needs in the rapidly growing and maturing cell and gene therapy industry.

NEXA was able to offer paperless validation service through ValGenesis, which provided the following key benefits:

• Online portal for improved collaboration
• Reduced review/approval cycle times
• Digital execution for improved legibility
• Final qualification package as a single PDF for easy record retention