Therapeutic Peptide Analysis Services
Work with us to accelerate your peptide therapeutic development. We offer comprehensive characterization testing and regulatory support, guiding you through every step of the process. From addressing stability challenges to ensuring regulatory compliance, our therapeutic peptide analysis services combine advanced technology with deep biological chemistry expertise to help expedite your path to market.
What is Therapeutic Peptide Analysis at Element?
Therapeutic Peptide Analysis involves comprehensive testing and characterization of peptide-based drugs to ensure their safety, efficacy, and regulatory compliance. At Element, we provide specialized analytical services throughout your peptide drug development lifecycle, from early characterization through regulatory submission support.
What can Element offer you for Therapeutic Peptide Analysis?
Components And Products We Test
Components And Products We Test
Our expertise spans stability testing, purity analysis, and advanced characterization of peptide-based drugs and related components.
Key Services Offered
Key Services Offered
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.
Element is adept at developing and executing innovative analytical methods. 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. This covers half-life, bioavailability, and target delivery.
Additionally, the solutions we offer include:
- 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
Cutting-Edge Equipment We Use
Cutting-Edge Equipment We Use
Leverage our state-of-the-art instrumentation for superior peptide characterization:
- Ultra-performance liquid chromatography (UPLC)
- Advanced mass spectrometers
- Capillary electrophoresis systems
- Cell culture facilities
- Stability chambers
- Spectroscopy platforms
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Materials we test
- Therapeutic peptides
- Peptide synthesis residuals
- Host cell proteins
- Clinical samples for PK/PD studies
Your Challenges, Our Solutions
Technical Property Challenges
Manufacturing Quality Control
Resource and Expertise Gaps
Regulatory Compliance Complexity
Why Choose Element
Complete Development Support
Advanced Technical Capabilities
Regulatory Navigation Excellence
Scientific Leadership
Frequently asked questions
What types of regulatory submissions can Element support?
We support INDs, BLAs, and certificates of analysis with comprehensive data packages and strategic guidance on filing approaches.
Explore our global network of labs and find your nearest location
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