Biopharmaceutical Development Support Services

Fundamental to your biopharmaceutical chemistry, manufacturing and controls (CMC) development, you will need detailed analytical characterisation data to satisfy regulatory requirements. Our experts strategically deploy orthogonal protein analysis approaches that address key molecular and biological characteristics relevant to ensuring the safety and efficacy of your specific product. This includes the requirements of the ICH Q6B Guidance such as total protein quantity, key physicochemical properties, the extent of heterogeneity within a sample and across batches, the intricacies of the biomolecule’s structure including post-translational modifications (PTM), higher order structure and assessment of aggregation. Biologic molecules are subject to degradation and our scientists are adept at developing and validating stability-indicating methods addressing potential decomposition pathways helping you to establish Critical Quality Attributes (CQAs) for your drug product. With integrated formulation and stability teams we can conduct forced degradation studies, determine what effect formulations have on higher order structure and use stability data to provide the next level of support if stability issues are observed. This includes expertise for the development and testing of inhaled biologics.

Meeting Regulatory Requirements
With a deep understanding of the latest regulatory developments, we can help you to meet the requirements for authorisation in all global regions, providing regulatory compliant data every time. Our experts ensure the data you need meets the requirements of Good Manufacturing Practice (GMP), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and OECD GLP regulatory standards. Our GMP laboratories conduct analytical programs to help you to meet specifications and support your regulatory submissions (investigational new drug application (IND) or new drug application (NDA) / biologics license application (BLA)).