Small Molecule Drug Development
Small Molecule Drug Development
Leveraging decades of expertise accelerating small molecule drugs from discovery to the clinic, our team of scientists provide the highest quality development support. For small molecule drug development programs, we offer end-to-end solutions across cell-based activity assays, HTS, ADME/DMPK bioanalyses, analytical characterization, impurity and excipient assessment, formulation development, and more.
ADME Profiling, DMPK Studies, and DDI Assays
We have extensive expertise in ADME, i.e., Absorption, Distribution, Metabolism and Excretion properties of small molecule drugs. We help Clients maximize potency for their lead molecule, identify critical drug metabolites, evaluate pharmacokinetic parameters, and minimize toxicity through drug-drug-interactions (DDI).
We offer an extensive array of standard ADME, DMPK, and DDI assays; however, our team specializes in customization, modifications, and de novo development of new assays for a specific program. Working both on the in vitro and in vivo front to help our Clients make critical go/no-go decisions for candidate selection, lead optimization, and subsequent preclinical development studies.
Our expansive laboratories are home to analytical, bioanalytical, medicinal chemists, as well as molecular and cell biologist under the same roof, significantly reducing project management timelines and tech transfer between bioanalytical team for ADME assays and medicinal chemistry team for lead optimization.
Our ADME, DMPK, and DDI assays include :
- CYP450 induction, inhibition, and phenotyping
- Hepatocyte, microsomal, S9 fraction, stability assessment
- UGT inhibition and phenotyping (recombinant supersomes)
- Metabolite profiling and ID: HRMS, MS/MS isolation of disproportionate metabolites, 2D NMR-based structure elucidation
- Protein binding assays via Rapid Equilibrium Dialysis (RED): plasma protein, whole blood, etc.
- Influx/efflux and permeability assays (PAMPA, Caco-2, MDCK/MDR-1, BCRP, P-gp, etc.)
- Bioanalysis: Pharmacokinetics, toxicokinetics (partner with qualified animal facilities), and biomarkers
- Bioanalytical method development and validation
- Custom and de novo assay development
Analytical Chemistry and Characterization Services
Scientists at Emery Pharma are experts in virtually all aspects of Analytical chemistry across drug modalities in the pharmaceutical discovery and development pipeline. On the small molecule front, we use state-of-the art instrumentation for isolation and analytical characterization during lead optimization, impurity identification including genotoxic impurities, degradation studies, excipients, and formulation assessment (stability, IVRT/IVPT, dissolution, etc.). Our analytical scientists work and brainstorm together with medicinal chemists, biologists, and bioanalytical scientist to solve some of toughest challenges in a new drug discovery program.
We offer extensive analytical chemistry capabilities to support all stages of small molecule drug discovery and development and follow guidance from FDA, ICH, and/or compendial methods as needed.
- Method Development, validation, test methods, reports, CMC documentation, release tests, stability package, and GMP compliance
- Characterization for lead molecules, NCEs, drug substance/drug products, excipients, etc. by analysis by HPLC (analytical, semi-prep, prep scale), SEC, IEX, LC-MS, HRMS, 1D and 2D NMR, GC-FID/MS, UV-Vis (VWD, DAD), charged aerosol detectors (CAD), refractive index (RI), etc.
- Impurity isolation and structure elucidation: process impurities, degradants, genotoxic/mutagenic impurities, etc. Access to qualified in-house 400 MHz, as well as 600, 800, and 950 MHz NMR equipment at partnering facilities
- Residual solvents/volatile impurities based on GC-FID/MS: Class 1-3 solvents, genotoxic nitrosamine panel, custom solvents and any other volatile impurities.
- Physicochemical characterization: logP/logD, solubility, optical rotation, enantiomers, IR, UV-VIS, X-ray DSC, solid state NMR, etc. (some performed at qualified partnering labs managed by Emery Pharma).
At Emery Pharma, our expertise covers all aspects of medicinal chemistry, from strategic planning to hit evaluation and validation to lead optimization and pre-clinical development. We have over 50 years of combined industry experience, and our team of seasoned scientists have experience in developing drugs from original concept all the way to FDA approval. All of these services are fully integrated within Emery Pharma allowing for a “one-stop shop” approach towards outsourcing lead discovery, optimization efforts, and associated analytical chemistry work.
Relevant services include:
- Designing synthetic routes for analogs, impurities, degradants, metabolites, etc.
- Total synthesis for target compounds from milligram to kilogram scale, associated reaction and reagent optimization, and reporting.
- Compound library creation.
- Synthetic protocol transfers to/from the sponsor and/or manufacturing facility.
- Troubleshooting specific optimization issues
- Analytical characterization of products, side-products, and intermediates via HPLC, GC, LC-MS, NMR, X-ray, etc.