THERAPEUTIC PEPTIDE ANALYTICAL DEVELOPMENT, CHARACTERIZATION & GMP TESTING SERVICES
nuvalore provides EU GMP certified analytical development, characterization, method development and validation, and GMP testing services for therapeutic peptides. By combining advanced chromatography and capillary electrophoresis through orthogonal analytical strategies, we generate regulatory-ready data to support product quality, process understanding, and regulatory submissions from early development through commercial manufacturing.
Analytical Challenges & Critical Quality Attributes for Therapeutic Peptides
Therapeutic peptides offer exceptional target specificity and promising therapeutic potential but present unique analytical challenges throughout development and manufacturing. Sequence-related impurities, charge heterogeneity, chemicaldegradation, aggregation, and stability limitations can all influence product quality, consistency, and regulatory acceptance. To ensure product quality, safety, and compliance, critical quality attributes (CQAs) must be identified, characterized, and controlled throughout the product lifecycle. Comprehensive analytical characterization is essential for understanding and monitoring these attributes during development, stability studies, and GMP quality control.
| Critical Quality Attribute | Why It Matters |
|---|---|
| Identity | Confirms correct peptide sequence and product composition |
| Purity | Demonstrates manufacturing consistency and product quality |
| Impurities | Supports regulatory compliance and patient safety |
| Charge Variants | Assesses molecular heterogeneity and product consistency |
| Aggregates & Fragments | Evaluates safety and stability risks |
| Stability | Supports shelf-life determination and storage conditions |
Analytical Techniques for Therapeutic Peptide
No single analytical technology can fully characterize a therapeutic peptide. nuvalore utilizes orthogonal chromatographic and capillary electrophoresis techniques to evaluate critical quality attributes throughout development and GMP testing.
Advanced Capillary Electrophoresis for Therapeutic Peptides
Capillary electrophoresis provides powerful complementary characterization of charge variants, purity, identity, and product comparability. These techniques can provide valuable information for therapeutic peptides, peptide conjugates, and other complex modalities, where subtle molecular changes can significantly impact product quality and performance.
| Imaged Capillary Isoelectric Focusing (icIEF) | High-resolution charge variant analysis and isoelectric point (pI) determination to support product characterization, comparability studies, and stability programs. |
| Capillary Zone Electrophoresis (CZE) | Rapid separation based on electrophoretic mobility (charge-to-size ratio) supporting purity assessment, identity confirmation, and detection of low-level degradants. |
| Capillary Isoelectric Focusing (cIEF) | Determines charge fingerprints and isoelectric point profiles to support product characterization and method development. |
| Micellar Electrokinetic Chromatography (MEKC) | Separates neutral and hydrophobic peptide species that may be difficult to resolve using conventional electrophoretic approaches. |
| Nonaqueous Capillary Electrophoresis (NACE) | Supports characterization of highly hydrophobic peptides using organic solvent-based systems. |
| CE-SDS | Provides size-based characterization under denaturing conditions and supports detection of fragments, aggregates, and size variants associated with complex peptide modalities and conjugates. |
High Resolution Chromatographic Characterization
Chromatographic techniques provide complementary information on peptide purity, impurities, aggregates, and stability, making them essential components of therapeutic peptide characterization.
| RP-HPLC & Peptide Mapping | Purity profiling, related substances analysis, stability studies, and peptide identity confirmation. |
| Ion Exchange Chromatography (AEX/CEX) | Characterization of acidic and basic variants to support charge heterogeneity assessments. |
| Size Exclusion Chromatography (SEC-HPLC) | Aggregate and fragment characterization under mild separation conditions. |
| HILIC & Mixed-Mode HPLC | Enhanced retention and separation of highly polar peptides while providing orthogonal selectivity relative to RP-HPLC. |
| Chiral HPLC | Detection of D-amino acid impurities and assessment of enantiomeric purity. |
| HPLC-CAD | Quantitative analysis of surfactants, excipients, and formulation-related components supporting formulation development and stability studies. |
Mass Spectrometry (LC-MS & LC-MS/MS)
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Molecular Weight Verification: Supports molecular weight confirmation and sequence verification as part of an orthogonal characterization strategy.
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Structural Modification Analysis: Identification and monitoring of site-specific chemical modifications, such as oxidation states, deamidation, or missing terminal residues.
GMP Testing Services for Therapeutic Peptides
Operating within an EU GMP-certified quality system and supported by Manufacturing and Import Authorization (MIA), nuvalore provides analytical testing services supporting clinical and commercial peptide programs.
| Service | Application |
|---|---|
| Release Testing | Batch release and specification compliance |
| Stability Testing | Long-term, accelerated, and ongoing stability studies |
| Reference Standard Qualification | Qualification and characterization of analytical standards |
| OOS/OOT Investigations | Scientific support for quality investigations |
| Routine QC Testing | Ongoing manufacturing and quality control support |
Regulatory Support
Methods are developed and validated in accordance with applicable ICH, USP, and Ph. Eur. requirements to support product development, regulatory submissions, and commercial manufacturing. For therapeutic peptide programs, analytical strategies are aligned with current peptide-specific regulatory expectations, including relevant guidance from the European Medicines Agency (EMA) on the development and manufacture of synthetic peptides.
Where appropriate, nuvalore incorporates Analytical Quality by Design (AQbD) and risk-based development principles to support robust analytical methods, stability- indicating assays, and lifecycle method management.
Why choose nuvalore?
- Advanced Capillary Electrophoresis Expertise: icIEF, cIEF, CZE, MEKC, NACE, and CE-SDS
- EU GMP-Certified Laboratory: EU GMP certification and MIA authorization.
Advance your Therapeutic Peptide Program
From peptide characterization and impurity profiling to method validation and GMP testing, nuvalore delivers the analytical expertise needed to support therapeutic peptide development with confidence.
Contact our team to discuss your analytical requirements and development
nuvalore GmbH
Paul-Ehrlich-Str. 1
D – 69181 Leimen
Phone
+49 (6224) 179 966 0
