Enabling the Biologic Drug Breakthroughs of Tomorrow, Today




BioAgilytix is tackling the complexities of large molecule drug development to help improve human health and deliver cures for patients with critical illnesses around the world.


What started in 2008 as a small bioanalytical lab and team of 10 in Durham, NC has grown into three global locations, more than 400 employees, and a world-recognized brand for specialized outsourced large molecule expertise. In fact, over the past 2 years (2018-2019), BioAgilytix supported more than 40% of the large molecule (biologic) drugs approved by the FDA.

So what are the driving forces that have propelled the CRO to become the innovative and influential organization it is today? First and foremost is a founding commitment to scientific rigor, quality, and service excellence. Led by the mantra ‘our IP is our people’, BioAgilytix has invested in finding and developing the best talent with expertise in the field of large molecule bioanalysis. Large molecule drugs, unlike their small molecule counterparts with simple, well-defined structures, are comprised of many heterogeneous molecules and are produced in living cell culture, which makes them much more difficult to control.


Their development therefore requires extensive specialized bioanalytical expertise, and BioAgilytix has built a world-class scientific team comprised of renowned experts in biomarkers, immunogenicity, biosimilars, gene and cell therapies, and other innovative therapeutic modalities.

More than half hold Ph.D. or Masters-level degrees, and the team in total averages over 15 years of post-schooling bench experience. The breadth and depth of both scientific and regulatory expertise available within BioAgilytix makes the organization highly sought-after by pharmaceutical and biotechnology sponsors worldwide – and its ability to deliver quality results is confirmed by the company’s stellar regulatory track record and leading customer service rating.

Demand for BioAgilytix’s services is being further spurred by the fact that sponsors are shifting more investments into large molecule drugs because they offer greater specificity to target complex diseases at the cellular level.


Today, 50% of the global development pipeline is focused on biologics and is expected to grow to over 70% within the next 5 years. This includes therapies addressing rare diseases, cancer, neurological and metabolic diseases, autoimmune disorders, and more.

BioAgilytix has remained committed to strategically scaling its operations to meet customers’ growing needs, adding resources and capacity to support development of more novel drugs that are giving patients new treatment paths. Today, in addition to their expanded GxP laboratory in North Carolina, they have an advanced facility in Hamburg, Germany that enables them to readily support global studies, and recently acquired a second US laboratory in Boston, the world’s largest hub of biotech innovation.

As the industry continues to trend toward precision medicine, custom therapeutics, and more targeted large molecule drugs, BioAgilytix is well-positioned to continue leading its market and enable drug innovators to realize a noble mission: bring lifesaving drugs to the marketplace quickly and safely.


BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With US headquarters in North Carolina’s Research Triangle area, a laboratory in Boston, Massachusetts, and European headquarters in Hamburg, Germany, BioAgilytix provides global services for biomarkers, immunogenicity, PK, and cell-based assays supporting the development and release testing of biologics across a number of disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, GCP, and CLIA as well as GMP quality control testing (i.e. product release testing, stability testing, etc.).


Year Founded: 2008
Chief Executive Officer: Jim Datin

Other INNOVATE® Ecosystems