Protein Characterisation and Analysis

In the manufacturing of biologics, ensuring the safety, efficacy, and quality of the final product is paramount. Protein analytics plays a crucial role in the quality control (QC) testing process by providing detailed insights into the molecular composition, structure, and function of biologic drugs. This ensures that every batch meets stringent regulatory standards and delivers consistent therapeutic effects.

Additionally, protein analytics is integral during the process development phase, where it helps in optimizing production conditions and scaling up from bench to commercial scale. By identifying critical process parameters and their impact on product critical quality attributes, manufacturers can ensure consistent quality across batches, in alignment with ICH Q6B requirements.

Eurofins BioPharma Product Testing provides complete characterization packages according to regulatory guidelines for biopharmaceutical products, such as the ICHQ6B guideline, to support formulation or process development, comparability studies, reference material (re)qualifications, and investigational manufacturing troubleshooting.

Leveraging cutting-edge technologies and our deep scientific expertise, we develop and validate methods in, as well as facilitate method technology transfers. With extensive knowledge of pharmacopoeia monographs, including USP and Eur. Ph. methods, we ensure accurate, compliant testing at every stage.

• Compendial Tests (e.g. appearance, clarity, color, pH, osmolality, particulates)
• Size and charge variants (e.g. size exclusion, CE-SDS, SDS-PAGE, IEX, peptide mapping)
• Glycosylation (e.g. N-Linked glycan profiling)
• Process-related Impurities (e.g. residual DNA and proteins, host cell proteins)
• Concentration
• Potency & Biological Activity

• Our extensive experience with various sample types allows us to customize testing to meet specific client requirements, all at a single location.
• Our laboratories are equipped with state-of-the-art instruments.
• With decades of experience, our teams support comprehensive development and clinical programs using release assays and supportive methods.

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