Identifying, Analyzing, and Controlling Particles throughout the Biopharmaceutical Product Lifecycle

Tuesday, March 25, 2014; 11 am-noon Eastern US time AND Tuesday, April 1, 10:00-11:00 Central European time

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

Moderator:

Rita Peters

Editorial Director
BioPharm International

Speakers:


Roland Schmidt, PhD

Senior Group Leader, F. Hoffmann-La Roche Ltd.
Pharma Technical Development Europe (Biologics)

Dr. Tara Sanderson
Formulation Services Manager
SGS M-Scan Ltd

IMPORTANT - PLEASE READ
This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Sara Barschdorf, sbarschdorf@advanstar.com.

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