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Online Live Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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Meet the training leader

  • Prof. Dr. Tudor Arvinte
  • Titular Professor of Biopharmaceutics, School of Pharmaceutical Sciences, University of Geneva, and CEO
  • Therapeomic, Inc. Basel, Switzerland
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Key topics

In use compatibility studies.

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.

Key takeaways

Understand

• Risk management and preventive actions concerning particulates
• Critical process and formulation parameters
• How to assess aggregates

Learn

• 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

Gain

• 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

Learn more

Physicochemical characterization of bevacizumab in undiluted 25 mg/mL drug product solutions

Physicochemical characterization of bevacizumab in 2 mg/mL antibody solutions as used in human i.v. administration

Defining the right diluent for intravenous infusion of therapeutic antibodies

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Delegate Fee

from 1396 € Buy

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