ALDEVRON, L.L.C

ALDEVRON, L.L.C. specializes in the manufacturing of biological products excluding diagnostics, with demonstrated expertise in the production and lifecycle management of blood-derived therapeutics and related biologics. Their technical capabilities center on Good Manufacturing Practice (GMP) compliance, aseptic processing, and regulatory-aligned biological product development, particularly in the context of federal research and emergency response needs. The contractor’s work involves precise control of biological materials, cold chain integrity, and compliance with FDA and NIH standards for non-diagnostic biologics, indicating deep familiarity with plasma fractionation, component purification, and product stabilization protocols. Their ability to execute de-obligation actions tied to NIH funding cycles suggests proficiency in federal grant administration and financial stewardship within the biologics supply chain. The company maintains a focused relationship with the Department of Health and Human Services, primarily supporting NIH and related arms through the delivery and management of critical biological materials used in clinical research and public health initiatives. Their engagement reflects a trusted role in sustaining the federal biologics pipeline, particularly for investigational and life-saving blood products requiring stringent quality controls and regulatory documentation. ALDEVRON operates exclusively within the biological product manufacturing NAICS 325414 sector, positioning itself as a niche supplier of non-diagnostic biologics to government-funded research and operational programs. This vertical specialization distinguishes them from broader pharmaceutical contractors, emphasizing precision manufacturing of complex biologicals under federal oversight. As a small business structured under the 2L entity classification, ALDEVRON is based in Prairie Rose, North Dakota, and currently holds no formal government certifications. Their geographic footprint is limited to this single location, yet their contract history indicates a strategic role in the federal biologics supply network, serving national health priorities through highly regulated, mission-critical manufacturing activities.