Characterize and optimize therapeutic peptide programs with Element’s deep bench of advanced technology and understanding of biological chemistry while generating characterization data required to meet crucial regulatory milestones.

Peptide therapies, coupled with advances in chemical synthesis, have opened new doors to new discovery opportunities, given their unique blend of properties, simple late-stage production and low manufacturing costs. Therapeutic peptides play a critical role as signaling molecules and hormones, and they continue to be valuable for interventions that closely mimic native interactions.

Although the barriers to entry are lesser, as complex biomanufacturing is not required, therapeutic peptides pose a number of challenges. Naturally occurring peptides can suffer from low bioavailability, chemical and physical instability, poor membrane permeability, and fast metabolism and elimination. Additionally, potentially hazardous residual components can be produced when peptides are manufactured through chemical synthesis, requiring identification, control and mitigation strategies to be in place before production can be scaled. Overcome these hurdles and expedite path-to-market with Element’s comprehensive peptide analysis suite of services, which have been built to maximize efficiencies, with a focus on peptide stability and efficacy.

Peptide analysis methods and capabilities

Peptides have unique properties and analytical needs and can be filed with health agencies as a small molecule, with small protein molecular characteristics. Strengthen your regulatory submission strategy with Element’s expert regulatory and scientific guidance regarding the best approach for each program, along with the assays, tools and techniques needed to deliver highly reliable results.

Therapeutic peptide analysis services

  • Forced degradation studies
  • Residual organic solvent determination per USP <467>
  • Purity/Potency assessment by HPLC (reversed-phase, size exclusion, ion-exchange, etc.)
  • Purity assessment by capillary electrophoresis (CE, CGE, cIEF)
  • Clinical samples preparation and testing for pharmacodynamics and pharmacokinetics studies by multiple reactions monitoring and LC-MS/MS
  • In vitro cellular potency in cell culture
  • In vitro activity assay method development
  • Residual host cell protein analysis
  • SDS-PAGE and Western Blot

The Element advantage

Leading healthcare brands trust Element’s unparalleled ability to understand the unique needs of peptide programs throughout the entire drug development lifecycle. Strengthen your peptide therapeutic program with our deep understanding of the identification and quantitation of chemical synthesis residuals and novel method development and validation for superior characterization and optimization at scale. Successfully navigate regulatory submissions with best-in-class data, documentation, and compliance for certificates of analysis, INDs, BLAs and beyond.

For more information about Element’s comprehensive suite of therapeutic peptide services, or to request a quote, contact us today.

Instrumentation

  • Capillary electrophoresis (CE, Protein Simple Maurice)
  • Ultra-performance liquid chromatography (UPLC, Agilent) with UV-DAD and FLD
  • High-performance liquid chromatography (HPLC, Agilent) with UV-DAD, Sedex, Varian, ELSD
  • Dionex ICS-3000 Ion Chromatography System
  • Seivers Total Organic Carbon Analyzer
  • Agilent 7500ce ICP-MS
  • AB Sciex Triple Quadrupole API 2000 and 3000 Mass Spectrometers
  • Waters Acquity UPLC with Xevo G2-S Quadrupole Time of Flight (QTOF)
  • Mammalian cell culture facility
  • Caron stability chambers (custom settings)
  • Metrohm 899KF Karl Fisher Coulometer
  • Perkin-Elmer Spectrum 65 and Spectrum 100 Fourier Transform Infrared Spectrometers (FTIR)
  • Perkin Elmer Lambda 365 UV/Vis Spectrophotometer
  • Fluorescent & UV plate readers

Our team of over 6,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.