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Protein therapeutics analysis solutions
Thermo Fisher Scientific provides a comprehensive suite of analytical solutions, optimized to support every stage of protein therapeutics development. Our tailored solutions deliver crucial insights, accelerating your drug development process and expediting your path to market. By leveraging our industry-leading technologies and products, we effectively address the diverse needs of protein therapeutics development.
Intact mass analysis yields the average or monoisotopic mass of the protein, crucial for large molecules like monoclonal antibodies (mAbs). By comparing observed mass to theoretical expectations, you confirm protein identity, integrity, and detect isoforms. Intact mass analysis also reveals insights into antibody drug conjugates (ADCs), drug to antibody ratios (DAR), sequence variations, impurities, and degradation products.
Discover the exact molecular weight of your protein samples with intact mass analysis using mass spectrometry (MS).
Routine workflows
Advanced workflows
Native intact analysis ensures accurate detection at higher m/z ranges with increased spatial resolution by maintaining crucial non-covalent bonds. With minimal sample preparation required, native analysis delivers comprehensive insights into biomolecules while maintaining their structural integrity.
Experience the power of native intact analysis (native MS), where proteins are ionized from a non-denaturing solvent, preserving their natural state.
Utilizing IdeS, a precise cysteine protease, subunit analysis simplifies sample preparation and data interpretation. This method offers a faster, more comprehensive approach, simultaneously characterizing multiple antibody attributes at the domain level.
Unlock detailed analysis of monoclonal antibodies with enzymatic digestion and reduction, breaking them down into easily separable subunits.
Peptide mapping involves digesting the protein into peptides, which are then separated and identified to reveal the full sequence information. From site-specific glycosylation to amino acid substitutions, this method provides a comprehensive view of your protein's landscape. With advancements in sample preparation, UHPLC, MS technology, and user-friendly software, generating accurate peptide maps has never been easier.
Discover the intricacies of your protein's structure with peptide mapping, offering a detailed breakdown of its amino acid sequence and post-translational modifications.
Variants like sialylation and deamidation require careful identification and, if necessary, removal. Traditionally, salt gradient cation-exchange chromatography is used for characterization, but it requires customization for each mAb. In today's fast-paced drug development landscape, an efficient and adaptable platform method is crucial. Explore charge variant analysis to optimize your biotherapeutic development process.
Explore charge variant analysis to understand the diversity within biotherapeutic proteins like monoclonal antibodies (mAbs). Different forms of charge variants can significantly impact the drug's structure, stability, and efficacy.
Utilize HRAM for accurate mass information, enabling precise monitoring and quantitation of product quality attributes. This approach enhances process understanding and control in manufacturing complex molecules from living cells. HRAM MS surpasses traditional tests, providing deeper product knowledge and eliminating multiple lot release tests. MAM measures critical quality attributes at the residue level, ensuring safer and more effective drugs through a “quality by design” approach. Experience the power of HRAM MS for seamless research to routine workflows.
Access deeper insights into biopharmaceutical drugs like monoclonal antibodies (mAbs), biosimilars, and antibody drug conjugates (ADCs) with the Multi-Attribute Method (MAM).
Advanced workflows
Routine workflows
Protein aggregates can cause dosage errors and immune responses, emphasizing the need for vigilant quality monitoring. Size-exclusion chromatography (SEC) and hydrophobic interaction chromatography (HIC) are used to assess aggregation levels and detect changes in protein structure and hydrophobicity.
Ensure the safety and efficacy of therapeutic proteins by monitoring protein aggregation, a process where protein molecules form stable complexes.
Explore the challenges of purifying recombinant biotherapeutics produced in non-human host cells like CHO, murine myeloma, and E. coli. HCP release during cell growth and harvest can affect drug product safety and efficacy. Accurate detection and quantification of residual HCPs is essential to comply with regulatory guidelines (ICH Q6B). Rigorous monitoring and purification techniques are necessary to address low-level contamination.
Leverage the power of Thermo Scientific Orbitrap technology for accurate HCP analysis for safe and effective biotherapeutics
Explore the intricacies of glycan analysis, which investigates carbohydrate modifications on proteins in biotherapeutics. Glycans can be O-linked or N-linked, and their attachment to amino acid residues varies. Glycosylation is a common process in over 60% of therapeutic proteins, but it poses analytical challenges. To meet regulatory standards (ICH Q5E and ICH Q6B) and ensure clinical efficacy, complex glycoproteins require thorough characterization.
Achieve thorough characterization of glycans leveraging Orbitrap mass spectrometry technology
By measuring the rate of hydrogen-to-deuterium exchange, HDX reveals solvent accessibility and offers insights into protein structure and conformation. In biopharmaceutical development, comprehensive structural characterization is essential. Even subtle local conformational changes can significantly influence safety and efficacy.
Explore the dynamic higher-order structure of protein-based therapeutics with hydrogen deuterium exchange (HDX) mass spectrometry (MS).
For Research Use Only. Not for use in diagnostic procedures.