Service Areas/Study Types

Get started on the road to clinic sooner with actionable data. Our team in Worcester can help you identify the appropriate studies to run and generate the most reliable data quicker than anyone else in the industry – all from a local source.

 

Our scientists at Worcester have expertise which span a wide range of therapeutic areas and can help guide you throughout the lifecycle of your project, from helping you tailor your study in the beginning, to interpretation of results. With one study director assigned to all of your projects, we can better predict your unique needs. We are fully equipped to customize your program, as our client base ranges from a one-person start-up, to global conglomerates. If your company is located in the Boston/Cambridge area, we offer a free local courier for compound and sample pick-up and drop-off for your DMPK analysis. Contact us for more information.

 

Discovery Bioanalysis

Our Discovery bioanalysis team provides rapid non-GLP bioanalytical data of small molecule drug candidate compounds and biomarkers by LC-MS/MS, thus, allowing for quick evaluation of PK/PD characteristics. We offer a suite of customizable assays across the drug discovery continuum which reduces cost, minimizes time spent, and satisfies data requirements. Our Worcester discovery bioanalysis team supplies:

  • Small molecule therapeutics and biomarkers
  • LC-MS/MS bioanalysis with over 25 systems
  • NonGLP team dedicated to providing rapid study initiation and completion
  • Logistical and scientific processes built for quality and speed
  • Expertise in: Bioanalysis Study Customizations
    • Small Molecules
      • NCE, prodrugs, biomarkers, peptides, metabolite monitoring
    • Therapeutic Areas
      • Oncology, ophthalmology, infectious disease, CNS, cardiovascular, orphan diseases
    • Study Types
      • PK Screening, cross-over, dose range finding, early toxicology, tissue distribution (cold), pharmacodynamic
    • Species and Matrices
      • Species: mouse, rat, canine, guinea pig, rabbit, mini-pig, porcine, NHP, human, woodchuck
      • Biofluids: plasma, serum, whole blood, urine, CSF, bile, aqueous and vitreous humors
      • Tissues: artery, brain, feces, heart, kidney, liver, lymph node, skin, spleen, tumor, various ocular tissues
    • Standardized fit-for-purpose assays
      • We offer a suite of standardized, fit-for-purpose, non-GLP assays to address client needs to manage cost and minimize time while satisfying data quality requirements
      • NCE: RGA 1 (screening), RGA 2 (lead optimization), RGA 3 (pre-IND)
      • Biomarkers: BAT 1 (Exploratory), BAT 2 (Short-Term Evaluations), BAT 3 (Long Term Evaluations)
      • Method development and qualifications as needed
    • Data Analysis
      • Phoenix (WinNonLin), Watson / NCA

 

DMPK/ADME

We can help you design and conduct a full DMPK analysis and ADME screening package from early candidate selection and lead optimization, to understanding the key drug metabolism and pharmacokinetic properties to support safety evaluations prior to first dose in humans and beyond.

 

In Vivo Pharmacokinetic (PK)

Our skilled Worcester study directors can help you design an optimal strategy and customize protocols to suit any drug discovery program. With large colonies ready for study starts, and expertise with dosing routes and sampling, our scientists help you get timely superior data.

  • In Vivo PK Study Customizations
    • Study ready mouse, rat, and canine colonies
      • Wide variety of rodent strains available
    • Large and small molecules with pre-approved IACUC dosing routes
      • Dosing: IV (bolus and infusion), PO, SC, IP, and more
      • Sampling: Blood, plasma, CSF, urine, bile, feces, tissues, and more
      • Serial micro-sampling
      • Bioanalysis by LC/MS/MS
    • USDA inspected, AAALAC accredited, On-site IACUC & Vet Staff
    • Data Analysis: Phoenix (WinNonLin) / NCA

 

In Vitro ADME

Many of our in vitro ADME assays have multiple experimental designs available to suit the different stages of the drug discovery and development pipeline, providing a flexible approach to ADME testing. The Worcester in vitro ADME team can perform the assays that best meet your needs for throughput and data resolution to achieve your project-specific goals, from discovery screening through to IND-enabling studies.

  • In Vitro ADME Study Customizations

    Absorption

    • Permeability
      • Caco‐2
      • MDCK‐MDR1
      • MDCK
    • Assessment of three major transporters

     

    Distribution

    • Plasma Protein Binding
      • Rapid Equilibrium Dialysis (RED)
      • Ultracentrifugation (UC)
    • Melanin Binding
    • Red Blood Cell (RBC) Partitioning (Blood/Plasma Ratio)
    • Tissue, Microsomal, Tumor, Blood, CSF, Purified Proteins
    • Aqueous Solubility
      • Kinetic
      • Thermodynamic
    • LogD (Octanol/Water Partitioning)

     

    Metabolism and DrugDrug Interactions

    • Metabolic Stability
      • Microsomes
      • S9
      • Hepatocytes
    • CYP450 Inhibition & TDI (IC50 shift)
    • CYP450 Induction
      • Enzyme activity
      • mRNA (RT-PCR)
    • Metabolite Profiling/Identification
    • CYP450 Reaction Phenotyping
      • Human liver microsomes +/- inhibitors
      • Recombinant enzymes (Supersomes)
    • Plasma, Buffer Stability

     

    Excretion & Toxicity

    • Cell Viability (Cytotoxicity)
    • Hemolysis (Blood Compatibility)

     

    Assay Customizations

    • Study design level (SDL)‐1 assays are designed for discovery screening needs, and typically involve testing at a single compound concentration or incubation time point.
    • SDL‐2 level assay designs are a more definitive or in‐depth approach and can involve customized assay parameters. These assays typically test multiple compound concentrations (for IC50 determination) or time points (for half‐life determination).
    • Capabilities range from screening 100’s of compounds per week to a custom-designed study for a single compound.
    • Assay options: matrix stability controls, additional replicates or control conditions, metabolite mass monitoring, calibration standard curves to measure back‐calculated concentrations

 

In Vivo Pharmacology – Oncology

Our Worcester oncology scientific team has extensive experience helping clients select optimal models and assays, as well as designing new models to meet the specific needs of a particular compound or discovery program.

  • Oncology Pharmacology Study Customizations

    Models

    • Non-GLP PK/PD and efficacy studies
    • Syngeneic models in immune competent strains
    • Xenograft models
    • Humanized models
    • Transgenic models
    • Knock-out/Knock-in models

     

    Experience with multiple modalities

    • Small- and Large Molecule
    • CAR-T cells
    • Adoptive T-Cell Transfer
    • Cancer Vaccines
    • Modified Blood Components

     

    Tools

    • Imaging (in vivo and ex vivo)
    • Flow cytometry Capabilities Identification of Tils (NK, Tregs and Macs with Data Analysis)
    • Data Analysis: LEGENDplex, FlowJo version 10, SoftMax Pro 7, StudyLog version 3

Discuss Your Project

 

Frequently Asked Questions (FAQs) About Our Worcester facility