Biopharmaceutical Analytical Development Support

Biopharmaceutical development, bioanalysis, analytical characterisation, potency testing, stability studies, formulation development, CMC support, regulatory compliance, quality control, immunogenicity, ICH Q6B, biologic drug development. Biopharmaceutical Development Support Services: https://www.intertek.com/pharmaceutical/biopharmaceuticals/ Intertek provides comprehensive biopharmaceutical development support services designed to help innovators accelerate the development, characterisation, testing and regulatory approval of complex biologic products. These services support a broad range of product types, including proteins, antibodies, vaccines, antibody-drug conjugates (ADCs), peptides, cytokines, oligonucleotides and biosimilars. Successful biopharmaceutical development requires a thorough understanding of product identity, purity, quality, safety, efficacy and potency. Intertek's scientific teams deliver integrated analytical, bioanalytical and potency-testing solutions that generate the data needed to support critical development decisions and meet global regulatory requirements. A key focus is detailed analytical characterisation, which is fundamental to Chemistry, Manufacturing and Controls (CMC) development. Using advanced and orthogonal analytical techniques, scientists evaluate critical quality attributes including molecular structure, physicochemical properties, heterogeneity, aggregation, post-translational modifications (PTMs), higher order structure and batch-to-batch consistency. These studies help ensure product quality and support regulatory submissions in line with international expectations such as ICH Q6B guidance. Biologic products are inherently complex and can be susceptible to degradation, structural changes and impurity formation - Intertek develops and validates stability-indicating methods to help identify and control critical quality attributes while ensuring product stability throughout development and commercialisation.