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Project Profile: SciSafe, Inc.

Vaccine production, cancer treatment research, and CAR-T therapy development facility finds a home in Amsterdam

MaryBeth DiDonna

MaryBeth DiDonna is managing editor, events for Lab Manager. She organizes and moderates the webinars and virtual conferences for Lab Manager as well as other LMG brands, enabling industry...

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Lab Manger speaks to Garrie Richardson, general manager of SciSafe, Part of Biolife Solutions, about the new SciSafe, Inc. lab facility in Amsterdam, Netherlands. The facility is located adjacent to Schiphol Airport and measures 47,000 sq. ft. Bilfinger Tebodin Netherlands B.V. worked on the lab. Site construction and biorepository setup was completed by August 15, 2021. EU IGJ regulatory and client audits were hosted and completed by October 15, 2021. 

Q: What was the need for this facility? Can you give an overall timeline from the original conception to the expected opening?

A: SciSafe, now part of Biolife Solutions, is an established world leader in biological and pharmaceutical materials storage, offering a more tailored approach to meeting the specific needs of our clientele. For this location, in particular, we partnered with a long-standing customer to develop outsourced storage for vaccine production, cancer treatment research, and CAR-T therapy development near their research facility in Amsterdam. Above and beyond the noteworthy benefits of using a certified specialist for sample management, the savings and value made possible when compared to the true costs of in-house storage are significant. With SciSafe managing storage services, research teams are better equipped to focus on what matters most—developing and advancing clinical treatments for life threatening diseases.  

Ultracold freezers' sustainability features help reduce climate impact.
SciSafe, Inc.

Q: What kinds of sustainability initiatives have been included in the design plan?

A: Love this question and that it is top of mind with the Lab Manager community. Building greener, more sustainable biopharmaceutical storage is paramount to the future of scientific research. Many often think it is a trade-off between meeting sustainability goals and the budget, but this is really not true anymore in today’s world. There are two main topics that come to mind when building a sustainable facility: 1.) Purchasing ENERGY STAR®-certified equipment, and 2.) implementing proper equipment maintenance. ENERGY STAR cold storage equipment can drive down energy use and costs, as well as operational costs such as HVAC system use. Our first step towards achieving high sustainability was deploying over 300+ Stirling Ultracold SU780XLE freezers operating in this location. They are built with US EPA SNAP-accepted foam insulation and help lessen our organization’s climate impact by using natural refrigerants during operation. Then, prioritizing regular maintenance such as clearing ice, defrosting freezers, dust removal and regular sample clean-outs contributes to optimum efficiency of cold storage units, prolonged equipment life, reduced energy and HVAC use and, most importantly, reliable system operation to keep samples safe.  

Q: Is there anything particularly unique or groundbreaking about your facility or the design plan?

A: This facility has state-of-the-art infrastructure redundancy from power to equipment and footprint. We are set up for inbound and outbound operations in an expeditious manner to better support cell and gene therapy (CGT) products, and we have built multiple partnerships with cold chain logistics organizations to streamline the distribution of time-sensitive CGT products to patients.

Q: What sorts of challenges did you encounter during the design/build process, and how did you overcome them?

A: The biggest challenge was met early on: location. The anchor customer we partnered with to build this facility needed samples to be quickly accessible and local to their research near a large logistics hub. Amsterdam was the ideal location for the facility, and the address we found within yards/meters of the runway at Amsterdam Airport Schiphol was even more so. Speed to build out a fully operational and compliant facility was the next hurdle. We faced the same COVID-related supply chain delays as the rest of the world but were able to implement infrastructure quickly once the equipment was received. Local and national permitting to operate came next, with recruiting, hiring, and training a brand-new team to meet EU regulatory and client requirements in a timely fashion. It was a sprint, but the result is incredible.

Q: How did you work together with other members of the project team to collaborate on this building? Can you talk about your communication strategies and any compromises that needed to be reached in order to advance the project?

A: The biggest collaborative step encountered on this project falls within the development and execution of our standard operating procedures. As mentioned, we were anchored to a major pharmaceutical manufacturer throughout this site development. That meant our procedures needed to closely mirror theirs and the audit trail needed to prove effectiveness. We employed daily touch points to ensure collaboration and client approval, built out security to our client’s regulated standards, and operated in seamless partnership to build a best-in-class facility that fully integrates with our client and their needs.  

Q: If a similar facility or program were to look at your lab facilities for inspiration, what do you think they will take away as an example of what they should also implement in their own lab?

A: First and foremost was our complete, open and honest communication with our client to meet their needs and regulatory requirements in a timely manner and create a seamless partnership. Looking forward, we hope to inspire the use of sustainable, “green” tools and innovative technologies to better support future scientific research. A facility like this one does not need to compete for extra budget, if planned properly. Often, upfront cost will pay dividends in operational savings in the long run. Be smart with your budgeting.