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This webinar will discuss how product development teams can control aggregation and particulate formulation to create stable biopharmaceutical products.

Starts

March 25, 2014

Ends

April 1, 2014

Location

Online

Biopharmaceuticals need a stable environment to ensure a long product shelf life. One of the main challenges in the development of stable biopharmaceutical products is the control of aggregation and particulate formation. This 60-minute webcast will discuss the mechanisms and processes through which aggregation can occur and ways in which product development teams can investigate particulate formation and its control through early stage formulation development. Experts will discuss how particles can potentially develop through the life cycle of a drug, describe regulatory expectations, and provide a review of analytical techniques available to assess protein aggregation and particulates for innovator drugs and biosimilars. A case study will demonstrate real-world examples of how particulates levels can be higher than expected when preformulation screening is not properly conducted.

Key Learning Objectives

  • Review regulatory expectations and industry concerns about protein aggregation
  • Assess the advantages and disadvantages of analytical techniques for measuring particles
  • Understand how particles develop during a drug’s lifecycle

Who Should Attend

  • Formulation scientists
  • Product development scientists
  • QA/QC personnel
  • Regulatory personnel
  • BLA and marketing authorization applicants
  • Laboratory scientists
  • Product development experts planning to enter the biologics or biosimilars market

With expert speakers:

  • Roland Schmidt, PhD, Senior Group Leader, Hoffmann-La Roche Ltd., Pharma  Technical Development Europe
  • Tara Sanderson, PhD, Formulation Services Manager, SGS M-Scan Ltd

Dates & Times:

  • March 25th, 11 am Eastern US
  • April 1st, 10 am Central European Time

For more information please contact:

Ferdinand Dabu
75 Passaic Avenue
Fairfield NJ 07004 US
t: +1 888 747 8782