Biopharmaceutical stability studies for proteins and antibodies including forced degradation, stability storage, structure, physicochemical and potency testing
Biopharmaceutical stability studies for biologic therapeutics are essential to assess sensitivity to factors that could cause aggregation and degradation which impacts biologic activity, product safety, and quality.
Changes in biopharmaceutical stability due to degradation, chemical or physical instability can alter protein folding and the protein 3-dimensional structure, affecting efficacy. A host of complex analytical methodologies may be required to determine stability and these must be justified and validated. Biological activity assays and the quantitative detection of degradation products are also required to comply with Good Manufacturing Practice (cGMP) compliant stability program. Environmental factors (such as temperature, exposure to oxygen or changes in pH), adsorption onto surfaces and interactions with excipients can all affect stability. In order to demonstrate the stability of biologics, forced degradation studies should be designed and conducted to determine stability-indicating methods suitable for ongoing stability studies.
Our scientists are adept at conducting biopharmaceutical forced degradation, accelerated stability studies, short and long-term stability studies for proteins, biosimilars, antibodies or other biologics. Our expertise in establishing stability-indicating profiles addresses potential degradation pathways for your specific biologic through stress testing and forced degradation. With expert stability-indicating analytical method development skills, we provide assurance that any changes in physicochemical properties, structure, aggregation, biological activity, visual appearance, impurities, excipient degradation, and container/closure interactions will be detected.
External factors such as interaction with formulation components and storage conditions can impact higher order structure and so it is important to characterise the impact of these factors on structure / conformational stability.
Our biopharma stability experts have in-depth knowledge of relevant ICH guidelines such as Q5C, "Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products", Q1A (R2) and ICH Q6B guidance to ensure we deliver regulatory driven stability data suitable for your biologic and regulatory submission documentation. We bring a diverse range of protein analysis techniques conducted in accordance with Good Manufacturing Practice (GMP) to meet your stability outsourcing requirements. With a global network of GMP compliant stability storage facilities, we provide fully qualified environmental chambers, fridges and freezers with continual monitoring and back-up systems.
Biopharmaceutical Stability Testing Methods:
One-Source Solutions for Biopharmaceutical Stability
Coupled with project management and regulatory support, Intertek's biopharmaceutical laboratory services drive your stability programs forward whilst our formulation development team use stability data to provide the next level of support if stability issues are observed. Our thought leaders have over 20 years’ experience in biopharmaceutical stability studies and stability testing to support across a wide range of product types; proteins, monoclonal antibodies, vaccines, PEGylated proteins, antibody drug conjugates, oligonucleotides, glycoproteins and biosimilars. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
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