Focused on your needs, our specialists provide exceptional precision bioanalytical services for a wide range of study types — working with you to accelerate development, meet your milestones, and ensure compliant, on-time regulatory submissions for your drug candidates.
We offer a full range of bioanalytical services conducted in state-of-the-art, purpose-built laboratories at our locations in the U.S. and Canada, with designated containment Level 2 areas for work with Risk Group 2 pathogens. Staffed by highly-skilled analysts, and shifts running 24/7 (as needed), we can process over 60,000 study samples per month. Precision bioanalytical services are available as stand-alone, or part of a package of services.
For additional information on our bioanalytical solutions, consult our fact sheets:
Our bioanalytical services subject matter experts are responsive and flexible throughout all stages of your drug development pathway. Our unique array of platforms and large list of validated assays ensures the most effective methods for your individual programs.
- 100+ highly trained regulatory bioanalysis specialists
- 25+ research and development scientists
- Capacity to accommodate 60K+ study samples per month
Our preclinical and clinical laboratory space in both the U.S. and Canada includes designated containment Level 2 (CL2) areas for work with Risk Group 2 (RG2) pathogens. Because of our work with NHPs, our preclinical site has BSL2 designation for various species. Our bioanalytical services analysts are available 24/7 depending on your program needs, to ensure that we process your samples within agreed-upon timelines.
Our team of dedicated bioanalytical scientists works with the latest equipment to provide bioanalytical services from discovery to preclinical and clinical pharmacology, in accordance with GLP and current FDA/EMA guidelines for both small and large molecules, including immunogenicity and biomarkers. Each bioanalytical validation and bioanalytical phase for sample analysis has an assigned Bioanalytical Principal Investigator.
We have experience with a wide spectrum of biological matrices in both animal species and humans, including serum, plasma, blood, urine, feces, tissues, cerebrospinal fluid, and vitreous humor. Our capabilities include supporting microsampling (Mitra® VAMS®) and dried blood spots for preclinical and clinical programs.
Assigned bioanalytical services study personnel maintain open and constant communication with key stakeholders through regular conference calls and data sharing, adjusting, and managing the project progression as needed.
SMALL MOLECULE BIOANALYTICAL SERVICES
Our over 20 years of experience with small molecules has provided an extensive in-house database of over 680 assays, with more being added all the time. We have delivered customized, unique solutions in derivatization, chiral separation, drug stabilization, and labile and multiple metabolite quantitation, using state-of-the-art instrumentation and protocols to achieve low quantitation limits with limited sample volume. Some small non-biological complex drugs (NBCD) such as iron sucrose are more suitable for our Ligand Binding platforms.
LARGE MOLECULE BIOANALYTICAL SERVICES
We are renowned for our vast experience in LC-MS/MS and Ligand Binding bioanalytical platforms. We evaluate each request and provide customized workflows to allow accurate quantitation using appropriate platforms (mass spectrometry and/or ligand binding). Our experienced and dedicated research and development scientists develop validation-ready assays, customized to your needs, using advanced instrumentation.
Our bioanalytical services teams are experts in working with biomarkers that aid in the translational of preclinical results to the clinic. Our bioanalytical scientists collaborate with our toxicologists and clinical pharmacologists to select the most suitable biomarkers that will provide fit-for-purpose results.