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Our forced degradation strategies are aimed at obtaining meaningful data about degradation mechanisms and identification of potential degradation species
Protein forced degradation studies are an integral part of biopharmaceutical development, involving biomolecule characterization, identification of degradation products, the establishment of stability-indicating methods, validation of such methods, formulation development support analysis and assay development and comparability studies. Our forced degradation strategies are aimed at obtaining meaningful data about the degradation mechanisms and identification of potential degradation species.
A range of stress conditions can be applied to the drug substance or drug product during forced degradation. Typical stress methods include: elevated temperatures, freeze-thawing, mechanical stress, oxidation, light, as well as exposure to the various materials and devices used in drug delivery. Whilst the requirements of stability testing are defined in regulatory guidelines, the standard procedures for forced degradation of therapeutic proteins are largely unavailable, except for guidance for photostability testing.
Intertek provide stressed stability packages tailored to the protein of interest, in order to identify appropriate stress conditions and recommendations for setting up forced degradation studies for the different phases of development. Forced degradation studies are available to support early stages of development and more comprehensive packages are available to support the late phase development.
Typical stress conditions can include:
• Elevated temperature
• Freeze-thaw cycles
• Mechanical stress
• Photostability testing according to ICH
• pH stress
• Forced oxidation
• Forced deamindation
• Shipment studies
• In-use stability studies
• Compatibility studies with various materials and drug delivery systems
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