Particle analysis & identification
Particulate matter is highly regulated in injectable drugs, including monoclonal antibodies and recombinant protein drug products. Problematic particles in these drugs include protein aggregates, excipients and formulation components, or process-related contaminants like plastics, cellulose fibers, or metals.
Most particle identification tools are limited to the types of materials they can identify. FTIR can identify protein aggregates and plastics but can’t handle metals or aqueous suspensions – which includes almost all protein-based drugs. SEM-EDS is good at identifying metals but not much else. Morphology-based particle identification techniques like flow imaging or microscopy can provide a guess at particle composition based on appearance but can’t confirm chemical or elemental make-up. This means you need at least two, if not more of these instruments to handle any possible problem particle.
The right tool for the job
Catch protein aggregation
Identifying protein aggregates is crucial when working with monoclonal antibody and recombinant protein drug products. Raman 532 nm is perfect for identifying proteins when aggregates show up – even allowing you to differentiate between different proteins based on their Raman spectra.
Track down any contaminant
Customize to your process
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Want to learn more about how Hound provides specific and customizable particle identification for organic, inorganic, proteinaceous, and metallic materials?