Purity Testing, Aggregates, and Stability Studies
Purity testing and evaluation of aggregation and stability in biological products to generate key data for quality control, comparability, stability studies, and product lifecycle management.
- Purity testing by RP-HPLC
- Aggregate quantification by SEC-HPLC
- Degradation and stability studies
- Support for comparability and change control
These methodologies allow the detection of variants, degradation products, aggregates, and fragments that may impact product quality, safety, immunogenicity, and consistency, using chromatographic methods adapted to the critical quality attributes of each molecule.
Their application provides useful information for analytical development, comparability, quality control, and regulatory strategy, especially when it is necessary to understand the effect of process, formulation, or storage changes.
We generate analytical evidence on purity, aggregation, and stability to support decisions in development, comparability, change control, and product lifecycle management, integrating these methodologies with other analytical capabilities when the project requires a more comprehensive view of the molecule.
What is purity testing and aggregate analysis in biological products using RP-HPLC and SEC-HPLC?
Purity characterization allows the identification and quantification of:
- Chemical variants
- Degradation products
- Post-translational modifications
Aggregate analysis evaluates the presence of:
- High molecular weight (HMW) aggregates
- Low molecular weight (LMW) fragments
Both analyses are essential to ensure the quality and consistency of biological products.
Main applications
- Quality control and batch release
- Stability and forced degradation studies
- Photostability studies
- Biosimilar development and comparability
- Process optimization for purification and formulation
What our purity testing, aggregates, and stability analysis service includes
1. RP-HPLC purity testing for biological drugs
The determination of purity and related substances by reverse-phase high-performance liquid chromatography (RP-HPLC) allows the detection of:
- Degradation
- Oxidation
- Deamidation
- Clipping
- Chemical variants
Technical features:
- C18 / C4 columns
- UV, fluorescence, CAD (Charged Aerosol Detection), and MS/MS detection
- High resolution and sensitivity
Applications:
- Recombinant proteins
- Monoclonal antibodies
- Stability and photostability studies
- Batch comparability
2. SEC-HPLC for aggregate analysis
Quantification of aggregates and fragments using size exclusion chromatography (SEC-HPLC) under native conditions allows evaluation of:
- Aggregates (HMW)
- Fragments (LMW)
- Biologic aggregation state
Applications:
- Quality control and release
- Process monitoring during purification
- Formulation assessment
- Forced degradation studies
Technologies and methodologies used
- RP-HPLC (Reverse Phase High Performance Liquid Chromatography)
- SEC-HPLC (Size Exclusion Chromatography)
- UV, fluorescence, CAD, and MS/MS detection
These techniques enable precise, reproducible, and robust characterization of complex biological products.
Regulatory compliance
To ensure the validity of results in regulatory and clinical contexts, our assays are aligned with:
- EMA (European Medicines Agency)
- FDA (Food and Drug Administration)
- ICH (International Council for Harmonisation)
Frequently Asked Questions (FAQ)
- What is the difference between RP-HPLC and SEC-HPLC?: RP-HPLC separates compounds based on hydrophobicity (ideal for purity), while SEC-HPLC separates them based on molecular size (ideal for aggregates).
- Why is aggregate analysis important in biologics?: Aggregates may affect product safety and immunogenicity, making them a critical regulatory parameter.
- What types of products can be analyzed?: Primarily monoclonal antibodies, recombinant proteins, and other complex biologics.
- Are these assays required for regulatory submission?: Yes, they are part of the required studies for development, comparability, and quality control according to EMA and FDA guidelines.
- Can methods be adapted to each product?: Yes, we develop and validate specific methods according to the characteristics of each biologic.
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