Therapeutic Peptide Analysis
With their unique blend of properties, peptide therapeutics have undergone a renaissance in recent years. They are typically safe and well-tolerated, with simple late-stage production and low manufacturing costs. However, they are not without their challenges. Naturally occurring peptides can suffer from low bioavailability, physical and chemical instability, poor membrane permeability, and fast metabolism and elimination. Manufacturing through chemical synthesis can also produce a range of potentially hazardous residual components, which need to be identified and mitigated before production begins to scale.
Overcoming these hurdles requires effective peptide analysis, with a particular focus on peptide stability and efficacy. Using a combination of technology and deep understanding of biological chemistry, Avomeen can help you characterize and optimize your therapeutic peptide program, while generating the characterization data you need to meet key regulatory milestones.
A deep understanding of chemical synthesis residuals and how to identify and quantify their presence.
The biochemical knowledge needed to develop optimal, scalable methods to characterize and select specification ranges.
Support with data, documentation and compliance for certificates of analysis, INDs, BLAs and other regulatory requirements.
Peptide Analysis Capabilities:
While peptides can be classified with health agencies as small molecules, they maintain certain molecular characteristics of small proteins. As such, they have unique properties and analytical needs. Avomeen offers guidance on how to best approach each program, along with the assays, tools, and techniques to deliver highly reliable results.
- 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
- Liquid chromatography/mass spectroscopy (LC-MS)
- Gas chromatography/mass spectrometry (GC-MS)
- Capillary electrophoresis (CE, Protein Simple Maurice)
- Ultra-performance liquid chromatography (UPLC, Agilent) with ELSD, 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
Avomeen is 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 like half-life, bioavailability, and target delivery.
Technical Progress in Therapeutic Peptides
Since the introduction of the 51-amino acid insulin peptide in the 1920s, peptide therapeutics have remained a prominent and impactful class of pharmaceuticals, notably as treatments for certain metabolic diseases, cancer, and infectious diseases. Given their pivotal role as signaling molecules and hormones, they continue to be valuable for interventions that closely mimic native interactions. For smaller companies, the barriers to entry are also lower as no complex biomanufacturing is required.
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 Avomeen’s peptide analysis capabilities can make a major impact.
Need Help with Peptide Analysis?
Avomeen understands the unique needs of each peptide program, making us an excellent partner throughout the development process. Give us a call, so we can help power your peptide therapeutics through IND, BLA, and beyond.