Workshop - San Diego, CA, United States
Biologic based drugs are most commonly administered parenterally. This causes special requirements in the composition of the formulation and the product specifications and also for the packaging materials and the method of manufacture (aseptic). Many of these requirements are specific to biotherapeutics, and this will be the specific focus of this workshop. In addition to the basics of the formulation, manufacture, and testing of these products, current developments and trends will also be discussed, in particular: device-combination products, developments in sterilization and lyophilization, high concentration formulation development and stability, the prevention, characterization, and immunological relevance of protein aggregates and particles, and relevant aspects of antibody-drug conjugate and biosimilar development.
The primary objectives are:
Review and discuss current trends and hot topics seen in biologics drug product development, manufacture, analytics, and bioanalytics.
Inform about excipients, development strategies, application devices, lyophilization, and other pharmaceutical processes, antibody drug conjugates, and protein analytical topics such as particle characterization, immunogenicity, protein pharmacokinetics, biosimilars, and intellectual property aspects.
Enable suppliers in the field to inform the audience about recent innovations.
Give newcomers in the field an overview but enable experts to discuss current challenges.
Give in a breakout session the opportunity for expert discussions on current painpoints.
For more information visit: AAPS Workshop on Biologic Drugs—Recent Trends in Formulation
Saturday, May 18, 2013 – Sunday, May 19, 2013
Sheraton Hotel and Marina, San Diego, CA, US
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