The determination of charge variants of therapeutic proteins is a regulatory requirement for pharmaceutical companies. This application note demonstrates the suitability of capillary isoelectric focusing (cIEF) to assess the charge heterogeneity of different types of monoclonal antibodies. Our results prove that the developed cIEF method can be used as a platform to obtain unique profiles for different IgGs and effectively resolve their charge variants, with enough sensitivity to identify differences between the innovator and its biosimilar.
Designing self-injection systems to deliver biological drugs into the subcutaneous space has specific challenges relative to those required for the safe and efficacious delivery of traditional pharmaceuticals. A quality by design approach can manage all the unavoidable competing requirements and balance performance, robustness, and usability.
Single-use technology equipped with a scalable distributed control system allows for collecting and sharing data while simultaneously creating a connected enterprise that grows with the pace of business.
Companies wanting to accelerate biomanufacturing operations and use resources efficiently need access to technologies and solutions that can safely and efficiently complete workflow from idea to injection.