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Formulation Development of Proteins and Antibodies: Fundamentals of Liquid Formulation, High-Dose Delivery, Non-Aqueous Formulations, and GI Delivery
Developing biopharmaceutical formulations that offer maximum patient convenience without sacrificing safety and efficacy for entities such as mAbs, antibody drug conjugates, and Fc-conjugates among others is increasingly complex.. Many drugs now require doses for subcutaneous delivery beyond what can be achieved with a 1 mL injection of an aqueous formulation. A significant hurdle in meeting this need is achieving the high drug concentrations required for these doses.
This workshop is structured to first provide an overview of pharmaceutical development. It will then showcase successful strategies across various areas, including developability assessments, surfactant use, achieving high-dose delivery via non-aqueous suspensions, and enabling the gastrointestinal delivery of biopharmaceuticals. The event will conclude with a discussion focusing on intellectual property within the drug product development landscape.
The workshop will cover the following key areas in pharmaceutical development of biopharmaceuticals:
- Strategies for Success: Successful approaches for molecule design, developability assessments, formulation design and minimizing surfactant degradation will be detailed.
- New Technologies: An overview of novel technologies enabling high concentration, high dose, and gastrointestinal delivery.
- Intellectual Property: A summary of the intellectual property landscape relevant to biopharmaceutical drug product development.
Key Topics
- Antibody engineering
- Pharmaceutical development roadmap
- Surfactant selection and degradation mitigation
- Developability assessment for high concentration biologics
- High concentration antibody landscape
- Novel strategies for achieving ultra high concentrations through non-aqueous suspensions
- Gastrointestinal delivery of biologics
- Intellectual property landscape for biologics drug product development
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