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.
When we pair ultra-high resolution mass spectrometry with our industry-leading expertise, the resulting data and scientific interpretation are unmatched in the contract preclinical research industry. We provide 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 significantly enhances 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 advanced spectrometry technique delivers numerous benefits in terms of speed, sensitivity and accuracy:
- 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 (such as biological and petrochemical).
- Identification of active and/or high-percentage metabolites in drugs to meet the requirements of the FDA 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: 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 five to 10 times faster than HPLC with up to two to three times the chromatographic resolution. This means much faster sample analyses and generally easier method development. Higher throughput 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: This allows us to obtain 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.
In addition to mass spectrometry capabilities, we offer 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
- Numerous spectroscopic techniques (NMR, UV/VIS, IR and Raman) for fingerprinting of macromolecules
- Ligand binding and activity assays with LAL endotoxin testing to support batch release of biologicals and biosimilars