High Resolution Mass Spectrometry Services
At Emery Pharma, we utilize the power of high resolution mass spectrometry (HRMS) through the Orbitrap Exploris™ 240 Mass Spectrometer to support both large molecule and small molecule analysis. For large molecules such as biologics, the Orbitrap Exploris™ 240 Mass Spectrometer enables detailed characterization, including peptide mapping, glycan profiling, charge variant analysis, and bioconjugate assessment. Its high-resolution capabilities ensure the accurate identification of structural variations and modifications critical for ensuring the safety and efficacy of protein therapeutics. Simultaneously, for small molecules, we utilize the Orbitrap Exploris™ 240 Mass Spectrometer to conduct precise quantitative analysis, metabolite identification, impurity profiling, and stability studies. By combining the versatility of this advanced technology with our expertise, Emery Pharma provides comprehensive, reliable data that supports every stage of drug development, from discovery through commercialization.
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Case Studies
Case Study 1
Background: The Drug-to-Antibody Ratio (DAR) of an Antibody-Drug Conjugate (ADC) molecule was determined using Native Size-Exclusion Chromatography coupled with Mass Spectrometry (nSEC-MS) utilizing Orbitrap Exploris™ 240 Mass Spectrometer.
Method: The ADC sample in PBS buffer was diluted to 10 µg/mL and analyzed using nSEC-MS.
Results: The obtained mass spectrum was deconvoluted using BioPharma Finder, revealing a DAR of 3.58.
Conclusion: The Orbitrap Exploris™ 240 Mass Spectrometer facilitated the resolution of overlapping peaks and accurate assignment of molecular masses to the different species, thereby enabling precise calculation of the DAR.
Case Study 2
Background: The purity of the Active Pharmaceutical Ingredient (API) was assessed, and potential transformations were identified using the Orbitrap Exploris™ 240 Mass Spectrometer.
Method: Samples were extracted with methanol and analyzed using UHPLC-UV/MS/MS.
Results: The UV chromatogram indicated the presence of multiple peaks in addition to the API peak. Furthermore, MS/MS data was used for Metabolite Identification (MetID) with Compound Discoverer, revealing oxidized and desaturated transformations of the API.
Purity Assessment
MetID
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Key Services
Fluorescence Detection for Trace Compound Analysis
Method Development and Validation
This technique offers unparalleled sensitivity and selectivity, especially for compounds at low concentrations. Fluorescence detection is ideal for both naturally fluorescing compounds and those chemically modified to fluorescence.
Derivatization for Non-Fluorescent Compounds
Biomarker Analysis
For compounds that do not naturally fluoresce, we utilize advanced derivatization techniques, ensuring even trace amounts can be detected and quantified with precision.
Quantitative Bioanalysis
Quantitative Bioanalysis
Fluorescence detection is used in conjunction with our LC-MS and UPLC systems to provide quantitative analysis in various applications. Our expertise ensures accurate, high-sensitivity measurements in complex sample matrices.
Applications
Emery Pharma's HRMS Services are applicable in a wide range of sectors, including:
Protein and Peptide Characterization
Intact mass analysis, peptide mapping, post-translational modification (PTM) profiling, and bottom-up proteomics.
Biotherapeutic and Biosimilar Analysis
Detailed characterization of monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and other biologics.
Metabolomics and Lipidomics
Comprehensive profiling of metabolites, lipids, and biomarkers for drug discovery and disease research.
Pharmaceutical Stability Studies
Degradation profiling, impurity identification, and forced degradation studies.