Comprehensive biopharmaceutical bioanalysis, analysis and potency services addressing the challenges of identity, purity, quality, safety and efficacy
Successful development of a biopharmaceutical or biologic medicine depends on ensuring the safety, efficacy, quality, purity and potency of your biopharmaceutical product.
To meet your biopharmaceutical development milestones, and comply with regulatory requirements, you will need quality data to aid informed decision-making. Safety assessment is paramount, as slight changes in the structure, physicochemical properties, potency and impurity profile of a biologic can provoke an adverse immune response if the biomolecule’s characteristics are not well understood. The complexity of biopharmaceuticals, such as proteins, present challenges to the assessment of structure, heterogeneity, aggregation / biophysical characteristics, physicochemical properties, stability and impurities, which can all impact product quality. The biological activity or potency of the drug is a key attribute that must be defined in order to control drug efficacy.
Characterization for a well-understood biopharmaceutical
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.
Ensuring regulatory requirements are met
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)).
Ensuring a safe and efficacious product
An in-depth knowledge of large molecule bioanalysis is required for safety assessment. Our Good Laboratory Practice (GLP) capabilities include developing and validating assays for pharmacokinetic (PK), toxicokinetic (TK), immunogenicity, efficacy and safety biomarker studies from early discovery through to late stage clinical studies.
Quality biopharmaceutical data to meet milestones
Our thought-leaders have over 20 years’ experience in biopharmaceutical development support across a wide range of product types including proteins, monoclonal antibodies, vaccines, PEGylated proteins, antibody drug conjugates, peptides, cytokines (e.g., interferons), oligonucleotides, glycoproteins and biosimilars. With broad capabilities in North America and Europe, our Total Quality Assurance expertise is delivered consistently to help you meet and exceed your quality, safety and efficacy requirements. Our experts provide strong scientific and technical leadership coupled with project management and regulatory support, to drive your development and manufacturing programs forward.
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