ICH, EMA and FDA guidelines demand stress testing of all drug substances and drug products. In order to ensure compliance, you need accurate testing to confirm stability indicating analysis, establish potential forced degradation pathways and allow characterization of product-related impurities.
We offer state-of-the-art laboratories and expert methodologies for forced degradation studies during early product development – performed according to ICH Q5C, Q6B and ICH Q1B to support license application in a cGMP compliant laboratory.
Why choose forced degradation for biologics from SGS?
- Design a study for your product with reduced scope offerings available to support programs in early or late product development life cycles
- Identify degradation products
- Establish degradation pathways and the intrinsic stability of the molecule
- Validate the stability indicating power of the analytical procedures used
- Characterize product-related impurities
Our forced degradation studies can help you assess the effects of:
- Mechanical stress
- Exposure to ICH light conditions
- High and low pH
- Temperature excursions
- Freeze and thaw stress
- Oxidation
- Humidity
Accurate pharmaceutical stress testing from a world-leading life sciences provider
Stability indicating methods for a wide range of biopharmaceutical products can be developed, validated and transferred under ICH’s guidance. The following analytical techniques are available for evaluation of forced degradation and stability studies:
- Imaged Capillary IEF (icIEF) and Agarose Gel IEF
- SDS-PAGE
- Capillary Gel Electrophoresis (CGE)
- UPLC and HPLC (SEC/RP/IEX/HIC)
- SEC-MALS
- Peptide mapping with UV, MS and/or MS/MS and/or MSe analysis
- Intact mass MS (MALDI-TOF and ESI-MS)
- Analytical Ultracentrifugation (AUC)
- Dynamic Light Scattering (DLS)
- Circular Dichroism (CD)
- Differential Scanning Calorimetry (DSC)
- Fourier Transform Infrared Spectroscopy (FTIR)
- Extrinsic and Intrinsic Fluorescence
- Bioassays/BIAcore
- Analyte Profiling (Neutral Glycans and Sialic Acids)
A full range of pharmacopeial and analytical methods are available for characterization and elucidation of product-related impurities.
As a world-leading provider of services to the life sciences sector, we offer unrivaled expertise in forced degradation studies, providing the largest network of contract testing laboratories. With 29 facilities across 15 countries, we offer clinical research services, analytical development, biologics characterization, utilities qualification, biosafety, quality control testing and stability studies for leading bio/pharmaceuticals across the world. Our dedicated laboratories are fully cGMP qualified and FDA/MHRA registered and inspected.
To find out more about our forced degradation studies for biologics, contact us today.
Av. De las Américas, Centro de Convenciones, empresarial 2 oficina 6,
090505,
Guayaquil, Ecuador