Tailored bioanalytical solutions for your most complex challenges
As increasing regulatory and scientific complexities threaten R&D productivity, you need a bioanalytical and ADME partner who can truly enhance the drug development process.
Solutions offers complete bioanalytical and ADME laboratory services for testing around the globe and across the product development spectrum. We combine knowledge from the collective services provided by our central labs
, bioanalytical and ADME labs network, as well as integration into global early clinical Phase I unit
. The result is timely, high-quality, regulatory compliant data that supplies the insights you need to make more informed decisions and instill confidence in your regulatory filings.
Our bioanalytical laboratory services include:
- Liquid chromatography–mass spectrometry (LC/MS) and ImmunoAffinity-LC/MS services for the quantitative determination of small molecule, peptide and macromolecule therapeutics in support of pharmacokinetic (PK) studies. See our methods list.
- In vitro ADME assays and metabolite identification services, including permeability, metabolic stability, metabolite identification (cold & radiolabeled), and in vitro drug-drug interaction risk assessment, ranging from highly automated discovery screening platforms to definitive development studies that enable regulatory submission. See our assay and services list.
- Immunoassay services, including quantitative determination of large molecule therapeutics using ligand binding technologies in support of pharmacokinetic (PK) studies and immunogenicity assessments for pre-clinical and clinical studies including tier based approaches, neutralizing assays, and isotyping assays. See our methods list.
- Fit-for-purpose biomarker services, including quantitative determination of discovery, pre-clinical and clinical biomarkers using LC/MS, Immunoaffinity-LC/MS, and Immunoassay technologies in GLP-compliant facilities. See our methods list.
We are one of the few bioanalytical laboratories successfully employing immunocapture, multidimensional (up to 3-D) liquid chromatography (LC) and high-resolution mass spectrometry (HRMS) for biological analyte LC/MS quantitation. We have an industry leading reputation in dried-blood spot (DBS) and dried-plasma spot (DPS) microsampling, and are one of the few service labs with experience in utilizing the HμREL® co-culture model to predict clearance and assess metabolic profiles of low turnover compounds.
We excel at employing innovative processes and finding custom solutions for our customers including scheduling flexibility and tailored project management support based on your project’s specific requirements. We know the importance of your deadlines and are willing to commit resources to meet your goals and timelines so you can keep your product on target.
We serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies in North America, South America, Europe and Asia with scalable expertise and innovative solutions.
|Indianapolis, IN, USA
- Home to our Center of Excellence for automated in vitro ADME screening, discovery LC-MS/MS
bioanalytical, in vitro metabolism, and metabolite identification capabilities
- Industry-experienced scientists and 24,000 square feet of lab space
|Ithaca, NY, USA
- GLP compliant bioanalytical liquid chromatography mass spectrometry (LC/MS) laboratory
- LC/MS biomarker assays in support of PK/PD studies
- HRMS, Nano-flow chromatography and Immunoanalytical/LC-MS hybrid assays
- TK and PK studies
|Marietta, GA, USA
- Home to our Immunoassay Bioanalytical (PK and immunogenicity) capabilities
- GLP compliant discovery bioanalytical/ligand binding assays - biologics and biosimilars
- Neutralizing immunogenicity cell-based assays
- Exploratory biomarkers
- GLP compliant bioanalytical LC/MS laboratory
- CAP certified for LC/MS biomarker assays in support of PK/PD studies
- Immunoassay (PK and immunogenicity) capabilities
We not only have the technology, systems, and processes to support your routine and complex projects, but we have 20+ years of experience and industry leading knowledge to provide key insights into the development of your product.
We can also help you develop methods for detecting your small and large molecule therapeutics, and to provide industry leading assays for immunogenicity assessments. The result is reliable, high-quality data for better decision-making, faster, more efficient drug development, and higher quality regulatory submissions.
Let’s improve human health together
to learn more about Q2
Solutions and how we can put our experience and expertise to work for you.
Watch our webinar on-demand here to learn about the latest trends and recommendations in protein therapeutics by immunoaffinity LC-MS