Effective Strategies for Managing Comparator Product Testing

Before a product within the same therapeutic class as another can be released to the market, comparator product testing must be performed to confirm that the product’s benefits outweigh that of the current, comparable product on the market.

There are many aspects of comparator product testing including, release testing of clinical supplies/materials for manufacturing, development and validation of assays, impurity and dissolution methods, stability studies and clinical release.

Most oral solid dosage form products are over-encapsulated for blinded clinical studies, which can present various challenges, including:

• Product sourcing.
• Final formulation selection (i.e. capsule shell, filler) that will minimize the risk of cross-linking.
• Determining method development needs for blinded clinical studies.
• Developing stability indicating methods.

The key to a successful comparator product testing project is allowing enough time to successfully complete the entire method development and validation process prior to study set-down in order to eliminate any risk of product-release delays due to unnecessary method-related result failures.

During this presentation, you will learn current strategies and best practices for comparator product testing, including:

• Strategies for sourcing and manufacturing.
• Processes for method development.
• Tactics and challenges associated with stability studies including cross linking.
• Tools to develop realistic timelines for successful project completion.

Speakers

Nathan T. Whitford, M.B.A., Manager, Chemistry and Site Operations, Eurofins Lancaster Laboratories, Inc.

With 14 years of analytical chemistry testing experience, Nathan Whitford oversees the development and validation of methods used in the testing of drug products and raw materials. He also manages analytical chemistry testing for release and stability studies and evaluates quality procedures and oversees facility operations for Eurofins Lancaster Laboratories’ Portage, Michigan location. He earned a M.B.A. from Eastern University and a B.S. in chemistry from Juniata College.

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Jutta Wagner, Head of Project Management Manufacturing, Fisher Clinical Services

Jutta Wagner is the current head of project management manufacturing overseeing the evaluation for new production procedures for clinical studies at Fisher Clinical Services where she oversees the evaluation for new production procedures for clinical studies. Her expertise lies in blinding dosage forms, API dosing, blends and alternative encapsulation technologies. Ms. Wagner has worked in the Pharmaceutical industry for over 20 years, in various manufacturing management roles, including a role on the executive board of SwissCo. Ms. Wagner holds a business and economics degree from the University Hagen, Germany.

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Chrissy Leslie, Manager, Pharmaceutical Product Testing, Eurofins Lancaster Laboratories, Inc.

Chrissy Leslie has 13 years of experience performing Pharmaceutical product testing for Eurofins Lancaster Laboratories, including microbiology and biochemistry. She specializes in dissolution, HPLC troubleshooting and writing/reviewing investigations. As manager of Product Testing operations for Eurofins Lancaster Laboratories, she oversees quality and compliance in order to meet client requirements and regulatory standards. Ms. Leslie earned a B.S. in biology from Millersville University of Pennsylvania.

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