Inhaled Biologic Drug Development

Intertek has over 30 years’ experience in biologics characterisation, from small peptides up to monoclonal antibodies and conjugated species, and contract testing, formulation and clinical manufacturing services supporting orally inhaled and nasal drug product development. The Intertek Centre of Excellence for Inhaled Biologics deploys a strategic programme of orthogonal analytical methods which aim to both fully characterise the biological entity and establish whether the device delivery mechanism (e.g. actuation through an inhaler) has adversely affected parameters. This includes the requirements of the ICH Q6B Guidance such as potency, protein structure characterisation and confirmation, total protein quantity, key physicochemical properties, post-translational modifications (PTM), higher order structure, assessment of aggregation, product-related impurities and process-related residuals.

With integrated formulation and stability teams, we use stability data to drive insight into the impact of the formulation and the device on the biologic including developing and validating stability-indicating methods and forced degradation studies. We have experience across nasal solutions / suspensions, nebulised solutions / suspensions and dry powders, offering a Center of Excellence to support you with formulation development, product performance testing, method development/validation, stability, CMC support and clinical manufacturing capabilities.