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Health

Pharmaceuticals

News and Updates

Projects and Programs

Orthogonal Measurements

Ongoing
Definitions: Orthogonal measurements: Measurements that use different physical principles to measure the same property of the same sample with the goal of minimizing method-specific biases and interferences. Complementary measurements: Measurements that corroborate each other to support the same
A schematic overview showing the distribution of the standardized samples to study participants, the use of standardized protocols for measurements, and standardized reporting of data back to NIST for analysis.

AAPS Interlaboratory Study: Protein Aggregation and Immunogenicity

Ongoing
To ensure the safety and efficacy of protein-based biotherapeutics, manufacturers strive to avoid unwanted immune responses caused by the biotherapeutic. Protein immunogenicity is a complex topic and depends on multiple factors related to the product, patient profile, and treatment. 1 , 2
Alex Rodriguez with data logger

Reliable Vaccine Storage

Completed
Our group examines best practices for the storage and monitoring of vaccines in partnership with the Centers for Disease Control and Prevention’s (CDC) Vaccine Supply and Assurance Branch. Vaccines are highly temperature sensitive, and inappropriate storage conditions can render them ineffective

Storage Stability of Freeze-Dried Proteins

Ongoing
Intended Impact Work in this project will enable industry to develop rational formulation approaches for freeze-drying, thus facilitating the manufacture safer, longer lasting biopharmaceuticals, with less time and resource cost required for stabilization. Biopharmaceuticals are the fastest

Publications