May 10, 2012

Webinar Series
Innovative Analytical Approaches to Expedite Product Development

Part 2: Timely and Thorough Extractables/Leachables Evaluations to Expedite Regulatory Approval

Speakers for this Event:

Derek Wood, Laboratory Manager, cGMP laboratory, PPD  

Istvan Kovacs, Ph.D., Senior Research Scientist, cGMP laboratory, PPD  

Contributor:

Xiaochun Yu, Ph.D., Principal Scientist, cGMP laboratory, PPD 

Timely and Thorough Extractables/Leachables Evaluations to Expedite Regulatory Approval

Nearly all drug product dosage forms require a thorough evaluation of extractables and leachables (E&L) prior to submission.* Failure to do so can result in costly delays in product approvals. Even worse, complications can result from inappropriate product packaging relating to E&L, which could have an adverse impact on the drug product formulation or cause patient exposure to unacceptable levels of leachables.

A thorough E&L evaluation includes a consideration of the primary and secondary packaging of the final drug product, as well as a review and understanding of the manufacturing process, including formulation, purification and filling processes, all of which may contribute extractables that could migrate into the final drug product to become leachables.

The Product Quality Research Institute (PQRI) publication “Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products” (September 2006) provides useful information regarding thresholds and approach in evaluating E&L for nasal and inhaled products. Although the PQRI working group for Parenteral and Ophthalmic Drug Products (PODP) is working toward a recommendation, currently there is little official guidance regarding the approach for these dosage forms.

This presentation will address:

• The importance of E&L for patient and product safety
• A well-planned and thorough E&L study design for the entire drug development and manufacturing process
• The types of E&L evaluations that are being performed for dosage forms other than just orally-inhaled and nasal products and which will help prevent delays in regulatory approvals

* Possible exceptions include solid orals and certain liquid oral products.

This webinar is Part 2 of a series on Innovative Analytical Approaches to Expedite Product Development.

• Chief Scientific Officers, Principal Scientists, VPs and Directors of Research and Development
• Chief Medical Officers, Medical Directors
• VPs, Directors of Technical Operations
• VPs, Directors of Purchasing

For large and medium pharma and biotech companies

Derek Wood is laboratory manager for analytical development in PPD’s cGMP lab, located in Middleton, Wis. He contributes a wealth of experience to the company’s analytical development operations with more than 20 years of experience in the pharmaceutical industry, including more than 15 specializing in the development and validation of analytical methods. Wood coordinates and conducts all aspects of management for extractables and leachables and gas chromatography-mass spectrometry (GC-MS) including certain analytical method development and validation teams within his department. He ensures project goals are met with strong resource and staff management skills. Wood also plans and directs the implementation of improvements in department systems, processes and procedures with a focus on increasing efficiency, productivity, compliance and client service.

Before joining PPD in 2001, Wood worked for Oread Labs, where he moved up from scientist to section manager. As a senior scientist with section manager responsibilities, he managed personnel and material resources for all of the company’s GC projects. His experience also includes a stint as laboratory analyst for Atochem North America, where he specialized in quality control for product purity tests and environmental control monitoring applications.

Wood earned a Bachelor of Science degree in biochemistry from Wichita State University.

Istvan Kovacs is senior research scientist and group leader for extractables and leachables services within the analytical development section of PPD’s cGMP lab, located in Middleton, Wis. He has seven years of experience in the pharmaceutical industry, specializing in all aspects of extractables and leachables services, such as designing, performing and managing controlled extraction studies of a wide range of packaging materials, containers and delivery devices for various pharmaceutical product formulations, as well as developing and validating analytical methods. His areas of expertise include organic chemistry, polymer chemistry, liquid chromatography-mass spectrometry, and gas chromatography-mass spectrometry.

Before joining PPD in 2005, Kovacs worked five years as a senior chemist for KiwiChem Intl., managing personnel and material resources, building and operating laboratory systems for purification and performing material characterization using high-performance liquid chromatography.

Prior to 2000, he spent more than 15 years in academia. He served as laboratory manager at McGill University in Canada, senior research fellow at the Research Group for Petrochemistry of the Hungarian Academy of Sciences, as well as various research positions at Queen’s University in Canada, the University of Ottawa and the University of Georgia.

Xiaochun Yu is a principal scientist for analytical development in PPD’s cGMP lab, located in Middleton, Wis. As the technical lead, he helps establish extractables/ leachables study capabilities at PPD. For more than ten years, Yu has led teams focused on extractables/leachables studies, method development and validation, utilizing high-performance liquid chromatography, gas chromatography, liquid chromatography – mass spectometry, gas chromatography – mass spectometry, etc. Yu also advises clients and colleagues on the design and execution of studies.

Before joining PPD in 2001, Yu worked for 10 years as a researcher for the U.S.D.A. Forest Products Laboratory in conjunction with the University of Wisconsin-Madison. He carried out comprehensive research on the characterization of cellulose and wood fibers, and developed several novel methods for that purpose.

Yu earned a doctorate degree in polymer chemistry from the Institute of Chemistry, Chinese Academy of Sciences and a Bachelor of Science degree in chemistry from Zhejiang University.

PPD is a global contract research organization (CRO) providing discovery, development and lifecycle management services. With offices in 45 countries and more than 11,500 employees worldwide, PPD has conducted clinical trials in over 100 nations, and we have worked with all of the top 50 pharmaceutical companies.

PPD is a leading provider of chemistry, manufacturing and controls (CMC) laboratory services for all phases of drug development and follows current Good Manufacturing Practices (cGMPs). Our cGMP laboratories provide fully integrated product and analytical development services ranging from early characterization through commercial release and stability. Our highly qualified cGMP lab staff works with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices. With more than 200,000-square- feet of cGMP laboratory space, we have locations in Athlone, Ireland; Middleton, Wis.; and Wayne, Pa., to meet our clients’ needs.

For more information, visit www.ppdi.com.