Bioanalytical Lab Solutions
Streamline your discovery and regulated bioanalysis with our comprehensive services, catering to a broad spectrum of modalities. Make informed decisions, faster, with the Bioanalytical Lab in Austin, Texas.
Scientific Depth
Small molecule, large molecule, biomarker and pharmacokinetic expertise supporting diverse therapeutic modalities and study designs.
Integrated Delivery
Connected CRU, laboratory, pharmacy and scientific teams supporting seamless sample and data flow.
Decision-Enabling Insights
PK, PD, biomarker and pharmacogenomic data interpreted within the context of broader clinical pharmacology strategy.
Small molecule
With a robust menu of 600 LC-MS/MS Fortrea Validated Methods and 1500 Total Methods, we provide assays that meet required sensitivity levels, including low pg/mL lower limits of quantification (LLOQs), using stable isotope-labeled internal standards for precise quantitation. Our experience extends to validating analytes in plasma, serum, and cerebrospinal fluid (CSF), underpinning our comprehensive support for First-in-Human (FIH) Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies.
Large molecule
We offer a comprehensive suite of services including method development, transfer, qualification, validation, and sample analysis catering to a wide range of biologics modalities—monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, fusion proteins, enzymes, oligonucleotides, and gene therapies. As a one-stop solution, we provide everything from reagent generation, labeling, and characterization to assay and sample management, logistic support, and data analysis, ensuring a seamless and efficient process for your large molecule projects.
Genotyping
Our Pharmacogenomics (PGx) services are tailored to understand the impact of genetic differences on individual drug responses. By predicting drug safety, optimizing dosages, and improving efficacy, our PGx testing supports successful clinical trials and informed decision-making. Whether you're developing small molecule drugs or exploring future applications for large molecules, our team can guide you through selecting the appropriate PGx panels and advise on sample collection for pivotal insights.
Biomarkers
Our laboratory in Austin, Texas is at the forefront of protein biomarker assay and sample analysis, supporting both discovery and GCLP biomarker studies. From biomarker identification and platform selection to assay development, assay validation, and PD data analysis, we offer a seamless integration of services. In collaboration with Fortrea late phase clinical development, our one-stop service extends to meeting the diverse biomarker needs within clinical trials, encompassing risk/safety, diagnostic, predictive, prognostic, and PD/response biomarkers.
PK/PD Data Analysis
Our experienced team can deliver comprehensive support for a broad spectrum of studies, including
- Bioequivalence/Bioavailability
- ANDA, 505(b)(2) submissions
- New formulations/routes of administration
- Early phase trials such as First-in-Human (FIH), Single and Multiple Ascending Dose (SAD/MAD) studies.
From initial study design and protocol development to the intricate assessment of bioanalytical assay ranges, our team expertly crafts statistical analysis plans, conducts detailed statistical analyses, and interprets data to empower your drug development with precision and insight.
Techniques and Platforms
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Techniques
- Ligand Binding Assays
- Mass Spectometry
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Instrumentation
- Quantstudio TM 3 Real-Time PCR System
- MSD
- LC/MS
- Spectramax
- Microlab Star
- Orbitrap Hi-Res Mass Spec Plate Readers
- Liquid Scintillation Counter
- Oxidizer to support radiolabeled AME studies
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Total Lab Automation
- STAR Pipetting Module
- Microplate Washer
- MSD QuickPlex SQ 120 Imager
- Incubator Shakers