Compatibility of biopharmaceuticals with primary packaging: characterization of leachables and extractables.
Studies of aggregates formation after mixing biopharmaceuticals with human plasma and human blood: Implications for in vivo toxicity and immunogenicity.
Examples of biopharmaceuticals will include: peptides, small proteins, antibodies, large proteins, biosimilars, different vaccines (based on proteins, nanoparticles, viruses).
Regulatory aspects regarding aggregates and particulates.
• Risk management and preventive actions concerning particulates • Critical process and formulation parameters • How to assess aggregates
• New orthogonal analytical method • Factors that induce protein aggregation and particulate formation in drug substances and drug products • Case studies of biopharmaceuticals in development and on the market
• Knowledge on utility and limits of predictive experiments • Insight into the diversity of aggregates and particulates present in biopharmaceuticals revealed by new orthogonal methods • Methods to study the aggregation of biopharmaceuticals in human plasma and human blood
Physicochemical characterization of bevacizumab in undiluted 25 mg/mL drug product solutions