51³Ô¹ÏÍø

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. Peptide therapeutics are a prominent and impactful class of pharmaceuticals, notably as treatments for certain metabolic diseases, cancer, and infectious diseases. Therapeutic peptides play a critical role as signaling molecules and hormones, and they continue to be valuable for interventions that closely mimic native interactions. For smaller companies, the barriers to entry are also lower, as complex biomanufacturing is not required.

Although the barriers to entry are lesser, 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. While this molecule is relatively accessible, companies pursuing peptide therapeutics do need access to specialized instruments, methods, and expertise to complete the necessary analytical testing for regulatory filings and future commercialization. As programs advance, there is also room for greater efficiencies to expedite the path-to-market. These are just some of the areas where Element’s peptide analysis capabilities can make a major impact.

Overcome challenges 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. Using a combination of technology and deep understanding of biological chemistry, we can help you characterize and optimize your therapeutic peptide program, while generating the data needed for regulatory compliance.

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.

A deep understanding of chemical synthesis residuals and how to identify and quantify their presence underpins our therapeutic peptide analysis service offerings. Our consultative teams of scientific and regulatory experts have the biochemical knowledge needed to develop optimal, scalable methods to characterize and select specification ranges. 51³Ô¹ÏÍøis adept at developing and executing innovative analytical methods that get to the heart of your therapeutic. Knowing the challenges associated with peptide activity and stability, our team can expertly access each peptide material to help you collect relevant data as you optimize your lead compounds for features such as half-life, bioavailability, and target delivery. Leading biopharmaceutical organizations rely on 51³Ô¹ÏÍøto provide best-in-class support with data, documentation, and compliance for certificates of analysis, INDs, BLAs and other regulatory requirements.

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

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

The 51³Ô¹ÏÍøadvantage

Leading healthcare brands trust Element’s unparalleled ability to understand the unique needs of peptide programs throughout the entire drug development life cycle. 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 Element’s consultative experts, regulatory expertise, and guidance as to how to best approach each program, along with the assays, tools, and techniques to deliver highly reliable results.

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