Biolife Solutions, Inc.

Biolife Solutions, Inc., a for-profit biopharmaceutical manufacturer based in Bothell, Washington, supplies cryopreservation reagents and automated thawing systems to the National Institutes of Health as a sole-source prime contractor, with all eight federal awards placed through non-competitive purchase orders carrying no set-aside designation.

Biolife Solutions operates exclusively as a prime contractor (100% of recent awards) in the in-vitro diagnostic substance manufacturing and laboratory instrument sectors. The vendor's federal footprint centers on two products: CryoStor CS10, a cryopreservation reagent validated under FDA Master File for cell-therapy manufacturing, and ThawStar, an automated thawing system. Both products support the NIH Clinical Center's Center for Cellular Engineering in the cryopreservation and handling of FDA-regulated cell-therapy products used in clinical trials. The vendor holds no subcontract relationships and does not participate in governmentwide contract vehicles, GWACs, or BPAs.

Customer concentration is narrow and stable. The Department of Health and Human Services' NIH Clinical Center accounts for 7 of 8 awards and $298 thousand of the $311 thousand combined potential value (96% coverage). The NIH Office of Logistics and Acquisition Operations placed a single $12,560 ThawStar purchase order in April 2023. All awards are structured as firm-fixed-price purchase orders under simplified acquisition procedures; the vendor's sole-source posture reflects CryoStor CS10's unique regulatory status as the only commercial cryoprotectant with FDA Master File approval and Biolife Solutions' validated manufacturing protocols with the NIH Clinical Center, creating process-revalidation barriers to substitution.

Award activity has grown modestly in recent years — one award each in 2022, 2023, and 2024, accelerating to three in 2025, with one award in August 2026. Recent representative procurements include a $44,738 firm-fixed-price purchase order awarded August 19, 2026, for 80 bags of CryoStor CS10 (completion September 18, 2026); a $24,948 order for CryoStor CS10 100-milliliter bags awarded December 24, 2024; and a $150,000 order for CryoStor CS10 covering July through December 2022, delivering 100 bags monthly. The vendor has fully obligated all $311 thousand in potential value across the award set, indicating strong execution.

Biolife Solutions' federal footprint is concentrated, specialized, and anchored to a single customer agency's sole-source demand for validated cryopreservation products. The vendor holds no broad-based vehicles, teaming relationships, or subcontract exposure; its competitive position depends entirely on maintaining the NIH Clinical Center's exclusive reliance on CryoStor CS10 and ThawStar for cell-therapy manufacturing operations.