Our biochemistry team provides cGMP support for all stages of biopharmaceutical development through manufacturing. We specialize in method development, validation, and transfer; cGMP batch release testing, impurity characterization and identification, drug substance and product stability and comparability studies, protein/peptide crystallization and solid state characterization, which is critical for lyophilized drug products.
SSCI provides ultra-high resolution Q-TOF mass spectrometry services for large and small molecule analyses. The Bruker maXis-Plus Q-TOF mass spectrometer is a state of the art instrument that will significantly enhance our capabilities in analysis and data interpretation for small and large molecules, including biologic drugs, metabolites and polymers to meet the expectations outlined in the ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. This sophisticated spectrometry technique will allow:
• Unambiguous assignment of molecular formulae for small molecules to larger molecules, including biologic drugs, metabolites, and polymers. This mass resolving power enables analyses in the presence of complex matrices (biological, petrochemical, etc.).
• Identification of active and/or high-percentage metabolites in drugs to meet the requirements of the United States Food and Drug Administration Guidance for Metabolites in Safety Testing (MIST) guidance. Q-TOF mass spectrometry is a fast and accurate analytical method for characterizing low levels of analytes. High resolution mass spectrometry can provide MIST information early in the development path.
• Enhanced sensitivity (versus previous-generation instruments): This is particularly important for impurity assays of drug substances and drug products. The limit of detection is in the pg/mL to fg/mL range.
• Extreme mass range: The Q-TOF MS has a range from 20 Da to 40,000 Da (assuming a singly-charged species; far larger masses can be analyzed if multiple charges are present). This enables analyses of small molecules, polymers, carbohydrates, oligonucleotides, and proteins such as antibodies.
• UPLC compatibility for LC-MS: UPLC chromatography is typically 5-10 times faster than HPLC with up to 2-3 times the chromatographic resolution. This means much faster sample analyse and generally easier method development. Higher through-put enables more rapid turnaround for large numbers of samples.
• CAD detection for UPLC: In addition to standard UV detection, state-of-the-art charged aerosol detection is available to enable analyses of materials without UV chromophores.
• MS and MS/MS capability for a wide range of molecules combined with detailed interpretation of the results for obtaining the most information from a limited amount of sample.
• MS of biologic drugs such as proteins, oligonucleotides, carbohydrates, and other polymers both biological and nonbiological. Sequencing of proteins from the N-terminus or C-terminus is also possible.
When this ultra-high resolution mass spectrometry service is coupled with SSCI’s industry-leading expertise, the resulting data and expert scientific interpretation is unmatched in the contract preclinical research industry. In addition to this new capability, SSCI offers a wide range of analytical technologies to characterize biologics and biosimilars, such as:
HPLC (RP, IEX, SEC, IC), gel electrophoresis (SDS-PAGE/Native PAGE; IEF) for separation and purity evaluation, N-Terminal Edman Sequencing and Amino Acid Analysis for protein identification, MALDI-TOF MS for molecular weight determination, Dynamic Light Scattering, SEC MALS, and SEM for aggregation state evaluation, and a variety of spectroscopic techniques (NMR, UV/VIS, IR and Raman) for fingerprinting of macromolecules. In addition, ligand binding and activity assays together with LAL endotoxin testing are provided to support batch release of biologicals and biosimilars.
Learn more about SSCI’s biochemistry services.