Forced Degradation

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?

We can help you:

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.