Peptide Impurities Testing
Reduce risks with robust impurity testing and contamination management. Utilizing cutting-edge techniques and a skilled team, we provide robust solutions to detect impurities and contaminants that can compromise the efficacy and safety of your peptide.
Unique combination of benefits
- Dedicated experts, equipment, and infrastructure for all impurity types and classes, ensuring robust impurity testing
- Extensive experience with hundreds of new chemical entities (NCE) and new biological entities (NBE) across modalities, drug substances, products, and dosage forms
- Broad panel of validated platform methods for streamlining the impurity testing processes
- Proven track record of validated, phase-appropriate methods for late-stage and commercial release
Comprehensive service solutions
From initial profiling to commercial control strategy, we provide a full suite of impurity testing services:
- Starting materials
- Peptide-related impurities from manufacturing
- Process-related (non-peptide) impurities
- Aggregation
- Degradation products
- Elemental impurities (Inductively coupled plasma optical emission spectroscopy (ICP-OES), Inductively coupled plasma mass spectrometry (ICP-MS), Atomic absorption spectrometry (AAS))
- Genotoxic impurities testing, including nitrosamine drug substance related impurities (NDSRIs), polycyclic aromatic hydrocarbons (PAHs), and alkyl halides
- Extractables & leachables
- Fermentation & cell culture components
- Bacteria/fungi, mycoplasma, viruses
- Residual DNA & host cell proteins
- Aggregation
- Degradation products
- Elemental impurities (Inductively coupled plasma optical emission spectroscopy (ICP-OES), Inductively coupled plasma mass spectrometry (ICP-MS), Atomic absorption spectrometry (AAS))
- Genotoxic impurities testing, including nitrosamine drug substance related impurities (NDSRIs), polycyclic aromatic hydrocarbons (PAHs), and alkyl halides
- Extractables & leachables
