We provide analytical testing services to meet the research and development challenges of the pharmaceutical and biotechnology industry
Operating from our GLP/GCP-compliant laboratories globally, we’ve provided bioanalytical support for over 14,000 studies for both small and large molecules.
Our responsive team of experts has earned a reputation for innovative method development as well as timely, high-quality analytical services that are personalized 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. We offer the highest quality services for pharmacokinetic, immunogenicity, biomarker, and CMC analysis, utilizing a wide range of platforms for small molecules, large molecules, and cell-based entities.
Biomarker assays: Bioanalytical meets CLIA
Reliable diagnostic, prognostic, predictive, pharmacodynamic, and pharmacokinetic biomarkers are critical to assure correct patient selection, drug dosing, and monitoring to get a patient a drug that is going to work for them. How a biomarker assay is being applied to a drug's development will determine when an assay should evolve from research quality to a clinical diagnostic test. In this on-demand webinar we discuss biomarkers for use as exploratory, primary, and secondary clinical endpoints and the regulatory requirements associated with their context of use.
View the on-demand webinar
With over 1,500 assays developed in support of over 2,500 studies and with management experience averaging 21 years, ICON Development Solutions has the bioanalytical expertise and track record required to deliver rapid, dependable results.
ICON’s method development teams have extensive experience developing and validating robust bioanalytical methods in blood, urine and tissue specimens to support pre-clinical and Phase I through Phase IV clinical trials with an average method development/validation time of 12 days.
Through our dedicated and highly experienced Quality Assurance groups, we deliver QA approved data to our sponsors within 5 days of study completion or on a run-by-run basis if desired. All reports are produced to appropriate regulatory standards, either in the client’s own format or in the default ICON standard, and final QA reviewed study reports are available to sponsors within 12 days from study completion.
Facilities: Whitesboro, NY
This 48,000 sq. ft. facility in Upstate New York houses 7 laboratories, including a specially designed hazardous lab for the analysis of HIV & Hepatitis B infected samples. Opened in 1988; GLP and GCP compliant since 1989. The lab provides bioanalytical services with three primary service lines:
- Quantitative immunoassays
- Large molecule and biomarkers
- Large molecule
- Plate and cell-based assays
- LC-MS/MS quantitative assays
- Small and large molecules and biomarkers
Facilities: Lenexa, Kansas and Assen, the Netherlands
These two sites offer state-of-the-art laboratories with new facilities opened in Q2 2019 (US) and Q2 2020 (NL). The Lenexa, Kansas lab is 48,000 sq ft. and the Assen, the Netherlands lab is 59,000 sq ft.
The two facilities adhere to stringent global regulatory guidelines, operating under GLP, GMP, or GCP regulations as applicable, and follow international guidances from the FDA, EMA and other regulatory authorities.
Both laboratories offer specialized and complex services, allowing ICON to offer truly global bioanalytical services. This includes:
- Support for clinical trials in China through our partnerships with two qualified laboratories
- Full service offering of PK/PD for small molecules and biologics in both laboratories
- Specialized and defined biomarker program with fit-for-purpose SOP governance; understanding the Context of Use concept for producing high-quality data
- Harmonized laboratories utilizing the same equipment, SOPs, and Electronic Laboratory Execution System
- Global leaders in analysis of large molecules by LC-MS/MS
- Global leaders in complex flow cytometry for regulated clinical studies