Preventing Unexpected Results in a GLP Study

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Virus Clearance Feasibility Studies to Prevent Unexpected Results in a GLP Study

Virus contamination in the manufacturing process can have not only serious clinical consequences but also economic ones, such as loss of public confidence and loss of time and money. To ensure patient safety, manufacturers must apply three complementary key approaches to viral safety as defined in ICH Q5A: selection of appropriate raw materials, testing of intermediate samples during production and removal/inactivation of viral contaminants.

To validate the latter, virus clearance studies must be performed – usually before investigational new drug application (IND) or biological license application (BLA). In addition, all changes must be evaluated and in some cases even re-validated. Changes in the purification process during development are not unusual. To reduce uncertainties and risks after these changes, feasibility studies provide the opportunity to evaluate and even optimize process parameters.


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In this webinar Sven Linz, Product Manager Validation Services, Finlay Logan, Product Specialist Virus Clearance and Sherri Dolan, Global Technology Consultant Virus Clearance will demonstrate how Sartorius' CONFIDENCE Virus Clearance Service can mitigate the risk of unexpected results in a GLP study, helping you to avoid development delays and cost overruns.


Key Learning Objectives

  1. Gain deeper insights into virus clearance in monoclonal antibody and recombinant protein processes
  2. Understand problem occurrences in GLP studies and how our service helps preventing them
  3. Learn more about the benefits of our services in combination with our virus clearance technologies

Meet Our Experts

Sherri Dolan

Global Technology Consultant for Virus Clearance

Sherri Dolan is the Global Technology Consultant for virus clearance and has been with Sartorius since 2005. Prior to joining Sartorius, she worked for 6 years at Millipore Corp. as a Process Development Scientist supporting all downstream technologies.  And prior to that, she had worked 10 + years at several Biotechnology companies focusing on downstream process development and clinical manufacturing of monoclonal and bispecific antibodies. Sherri holds a degree in Biochemistry.

Sven Linz

Product Manager of CONFIDENCE® Validation Services

Sven Linz is the Product Manager of CONFIDENCE® Validation Services since January 2020. He holds a Master’s degree in Marketing, Energy, and Process Engineering. Sven has gained first-hand marketing experience while working for an international startup accelerator based in San Juan, Puerto Rico. In addition, he has been working as a management consultant with a focus on organizational development of an R&D department at Volkswagen.

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