Bioanalytical laboratories

* last 5 years

We offer the highest quality services for pharmacokinetic, immunogenicity, biomarker, and CMC analysis, utilising a wide range of platforms for small molecules, large molecules, and cell-based entities. Our three GLP, GCP and GMP compliant laboratories are strategically co-located with ICON’s early phase clinical research units to foster innovative, cross-functional team collaboration and to facilitate the rapid analyses of time-critical samples and support fast dose escalations that are so crucial in today’s adaptive trials.

ICON’s responsive team of experts have earned a reputation for innovative method development as well as timely, high-quality analytical services that are personalised to meet each client’s specific application. We perform both stand-alone bioanalytical and immunoassay services, as well as the bioanalytical component of full-service packages across all phases of development. 

Facilities

We have three bioanalytical laboratories located in Whitesboro (New York, US), Lenexa (Kansas, US), and Assen (The Netherlands) All three facilities adhere to stringent global regulatory guidelines, operating under GLP, GMP, or GCP regulations as applicable, and follow international guidance from the FDA, EMA and other regulatory authorities. These harmonised laboratories utilise the same equipment and SOP's to deliver consistent and reliable reults.

We offer specialised and complex services including:

• Full service offering of PK/PD for small molecules and biologics
• Immunogenicity assays
• Specialised and defined biomarker program with fit-for-purpose SOP governance; understanding the Context of Use concept for producing high-quality data
• ADME services
• Support for clinical trials in China through our partnerships with two qualified laboratories

Our range of testing includes the following:

• LC-MS/MS
• Ligand Binding Assays
• Biomarkers
• Flow Cytometry
• qPCR
• Isotope Laboratory