Intertek ASG Laboratory, Manchester, UK > Pharmaceutical and Biopharmaceuticals > Biopharmaceutical Stability

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Biopharmaceutical Stability Studies

Biopharmaceutical stability studies require advanced analytical capabilities integrated with compliant quality systems. Intertek offers stability storage and advanced analysis capability for stability studies on biopharmaceuticals such as recombinant proteins, monoclonal antibodies, vaccines, etc. Biopharmaceuticals can be particularly sensitive to environmental factors and so the objective of a stability study will be to evaluate the quality of a biopharmaceutical product under various environmental conditions over a specific timeframe.

Stability studies for protein products can involve a range of analytical technologies which are available to GLP/cGMP:

• 1-D and 2-D SDS-PAGE
• Western blot
• Isoelectric focusing
• Amino acid analysis
• CE
• Peptide fingerprinting
• Peptide mapping / sequencing by LC-MSMS
• Total protein quantification
• Glycan characterisation
• Immuno-chemical techniques

Advanced analysis techniques may also be required to probe post translational modifications such as:

• Di-sulphide bridge mapping by MALDI-MS
• Carbohydrate analysis
• Secondary structure and aggregation status by dynamic light scattering

The basic stability study requirements are described in the ICH guidelines Q1A(R2): Stability testing of new drug substances and products and Q5C: Quality of biotechnological products: Stability testing of biotechnologicals / biological products. During early drug development accelerated stability studies can provide shelf life data and information on the effect of short term exposure to environmental conditions outside of the normal label storage conditions (performed over 6 month timespan). A long-term stability study - (timespan of 12 months up to five years) allows evaluation of the quality of the drug both during and beyond its projected shelf-life.