Smithers Launches Preclinical Generic PK Assay to Reduce the Time for Pharmaceutical Development

Smithers Launches Preclinical Generic PK Assay to Reduce the Time for Pharmaceutical Development

Published: 4/9/2024

(Gaithersburg, MD) – April 9, 2024 - Smithers, a leading provider of testing, information, consulting, and compliance services, announces the launch of its Generic Pharmacokinetic (PK) Assay.

The generic PK Assay was designed and developed by a Smithers team of expert scientists to address the growing need for more adaptable PK testing solutions in preclinical bioanalysis. This assay reduces the time to develop test article specific PK immunoassays, thereby accelerating the drug development process. The assay measures drug concentration of human or humanized mAb kappa IgG molecules with ECL detection. This method could be validated for specific IgG1, IgG2, and IgG4 molecules present in mouse and cynomolgus monkey serum samples. 

Key features of the generic PK Assay:

Efficient Workflow:  Allows for faster PK concentration data turnaround times. 
Good Performance in Sensitivity: Utilizes ECL detection to ensure precise quantification of drug concentrations, even at low levels.
Broad Applicability: Capable of analyzing a diverse array of novel drugs in preclinical development to support PK/PD and toxicology studies.

“The launch of the generic PK Assay underscores Smithers dedication in supporting pharmaceutical development through developing “off the shelf” assays that can be used for multiple preclinical programs. Smithers is helping to expedite the development of therapeutics in the preclinical stage,” states Christina Satterwhite, President, Smithers Pharmaceutical Development Services Division. 

Located in Gaithersburg, MD and Ewing, NJ, Smithers Pharmaceutical Development Services Division, a bioanalytical contract research organization (CRO), supports the development of large molecule therapeutics from discovery through post-market, with expertise in bioassays and ultra-sensitivity ligand-binding assays. Our services focus on development, validation, and sample analysis for PK/TK, ADA, bioassays, and fit-for-purpose biomarker studies. Smithers supports the development of biologics, monoclonal and polyclonal antibodies, bi-specific antibodies, CAR-T, TCR, and Biosimilars. Additionally, Smithers supports Cell and Gene Therapy Studies.

For more information about our services, contact Connie Scott at or call 240-723-0312. For more information about Smithers, please visit


About Smithers:
Founded in 1925 and headquartered in Akron, Ohio, Smithers is a multinational provider of testing, consulting, information, and compliance services. With laboratories and operations in North America, Europe, and Asia, Smithers supports customers in the transportation, life science, packaging, materials, components, consumer, cannabis, commodities, and energy industries. Smithers delivers accurate data, on time, and with high touch, by integrating science, technology, and business expertise, so customers can innovate with confidence.
Show Policy

Latest Resources

See all resources