BioAgilytix Completes Bioanalytical Laboratory Expansion at Its USA Headquarters

The Addition of Nearly 21,000 Square Feet Increases Capacity to Support Even the Largest Studies and Sample Analysis Needs

September 7, 2017—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has completed the expansion of the laboratory facility within its USA headquarters located in the Research Triangle area of North Carolina. The build-out adds nearly 21,000 square feet to BioAgilytix’s campus including new state-of-the-art lab space, bringing its total footprint to more than 48,000 square feet and more than doubling its cell culture facility. In fact, the new space increases the lab’s cell-based assay capacity by more than six suites, ensuring the resources to support large Phase III studies and demands for analysis of large sample numbers.

Reinforcing BioAgilytix’s commitment to remain a leading Good Manufacturing Practice (GMP) facility for large molecule bioanalysis, the expanded lab space also features a new dedicated GMP suite, providing a precisely controlled environment for work related to the biotherapeutic production. “As a company, we have always been committed to meeting all requirements and industry standards,” said Anita Simkins, Vice President of Global Quality Assurance at BioAgilytix. “Our new facility will expand our GMP capabilities and allow us to continue analysis of biologicals. I see this being an important resource for our scientists moving forward.”

Overall, the expansion will allow BioAgilytix to easily accommodate future growth and further solidify the lab’s ability to provide best-in-class bioanalytical capabilities with additional capacity and technology that enables efficient turnaround times. “This build-out was designed specifically to increase our capacity for studies at every phase in key development areas like cell-based assays, biomarkers, and immunogenicity,” said Afshin Safavi, Global Chief Scientific Officer at BioAgilytix. “We will now be able to utilize additional scientific talent and tools to further increase efficiencies and more seamlessly tackle customers’ complex challenges.”

“This expansion marks the next phase of methodical growth for our company,” said Jim Datin, Chief Executive Officer of BioAgilytix. “Our new advanced suites, and the increased capacity that comes along with them, mark our commitment to providing superior science and customer service while adhering to demanding turnaround times. It only enhances our ability to deliver expert capabilities for every phase of study, from discovery to global Phase III trials.”


About BioAgilytix

BioAgilytix is a leading global bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, and GCP, as well as product release testing under GMP.

BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 23 of the top 25 global pharmaceutical and biotech companies. For more information, visit

Media Contact:
Jennifer Absher
(919) 287-1573
[email protected]

Featured Expert

Pharmacokinetics & Pharmacodynamics​

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.
220328 Adleverage_Scientific Icon Illustrations_#46-65_CO_Per FIles