Skip to main content

Dissolution Best Practices

Description

1:30 PM – 1:35 PM
Introduction and Welcome
Yan Wu, Ph.D., Merck

1:35 PM – 2:00 PM
Designing a Science-Based Approach
Andreas Abend, Ph.D., Merck

2:00 PM – 2:25 PM
Global Best Practices
Tessa Carducci, Ph.D., Merck

2:25 PM – 2:50 PM
Dissolution Testing with Apex Vessels
Beverly Nickerson, Ph.D., Pfizer

2:50 PM – 3:15 PM
Dissolution Apparatus Qualification Criteria
Bryan Crist, Ph.D.

3:15 PM – 3:40 PM
The Hydrodynamics of the USP Apparatus 1 (Basket Apparatus)
Piero Armenante, Ph.D., New Jersey Institute of Technology

3:40 PM – 4:10 PM
Panel Discussion

4:10 PM – 4:15 PM
Closing Remarks

Contributors

  • Andreas Abend, Ph.D.

    Andreas Abend received his doctorate degree in natural sciences from the University of Karlsruhe in Germany. He was a Post-Doc at the University of Wisconsin’s Enzyme Institute before he started his career with MSD. Andreas is currently a Director in the Analytical Sciences department of MSD leading a group of scientists supporting new drug product development. He is a member of Merck’s Biopharmaceutical Advisory Team, PQRI’s BTC, and co-chair of IQ’s dissolution working group. Andreas is also a member of AAPS, ISPE and ACS.

  • Piero Armenante, Ph.D.

    Piero M. Armenante, Ph.D., is Distinguished Professor in the Department of Chemical and Materials Engineering at NJIT-New Jersey Institute of Technology. He has previously worked in industry and international organizations and serves as consultant for pharmaceutical companies. Until recently he was the Director of the Pharmaceutical Engineering Program, which he co-developed in 2002. He is very active in research, focusing on the study of single and multiphase mixing systems, stirred vessels, dissolution testing apparatuses, and testing devices, with emphasis on pharmaceutical applications. He is the author of more than 90 peer-reviewed publications, books, and book chapters, and many other publications and reports. He has organized and has served as Chair of many national and international conferences. He is Past President and Founding Member of the North American Mixing Forum (NAMF) of AIChE, where he currently serves as a member of the Executive Council. Prof. Armenante is the recipient of the North American Mixing Forum Award for Contribution to Mixing Research and Practice, the Harlan J. Perlis Research Award, the Saul K. Fenster Excellence in Innovation Award, the Excellence in Teaching Award for Excellence in Graduate Instruction in 2008, and the Excellence in Teaching Award for Outstanding Professional Development in Teaching.

  • Tessa Carducci, Ph.D.

    Tessa Carducci is an associate principal scientist at Merck & Co. based in Rahway, NJ working in the Analytical Commercialization Technology department. She graduated with a BS in Chemistry and minor in Psychology from Duke University and a PhD in Analytical Chemistry from UNC-Chapel Hill. At Merck, Tessa has worked on real time release strategy development and pioneered predictive dissolution modeling for release for a new drug product. Her primary areas of focus at Merck include subject matter expertise in dissolution and global filing requirements. She also enjoys implementation of novel analytical techniques, strategies for commercialization and world class supply, problem solving, and navigating new regulatory requirements. Outside of work Tessa enjoys taking care of her dog, skiing and snowboarding, traveling, and trying new foods.

  • G. Bryan Crist, Consultant

    Bryan is currently the president of DissoAssist consulting based in Wilmington, NC. He provides consulting, coaching, and training services for dissolution and drug release in the pharmaceutical industry, specifically, the areas of product and method development and validation, technology transfer, regulatory and compendial compliance, automation, troubleshooting, aberrant data investigation, apparatus and instrument qualification, SOP development, and laboratory audits.

    Previously, Bryan was a Scientific Affairs Manager with Agilent Technologies located in Cary, North Carolina, USA. Since 1979 he has performed analytical testing, supervised, and managed pharmaceutical laboratories with Bristol-Myers Squibb, Merck, AAI and Abbott Laboratories until 1997 when he joined VanKel, a dissolution equipment manufacturer. Primary responsibilities have been in the fields of product release, stability, product development and support, HPLC and dissolution method development and validation, instrument qualification and calibration, technology transfers, training, as well as NDA and ANDA submission and review. Current activities since 1997 have focused on providing method and technical application support for dissolution and drug release testing in the pharmaceutical industry as well as working with VanKel, Varian and eventually Agilent R&D, Marketing and Sales teams.
    Bryan has developed and routinely conducts numerous seminars covering Fundamentals of Dissolution, Advanced Dissolution, Dissolution Method Development and Validation and numerous regulatory compliance and pharmacopeial topics related to dissolution and drug release testing. He provides numerous talks at exhibitions and conferences and has published numerous articles in journals and book chapters on dissolution related techniques and topics. He received his B.S. degree in Chemistry from Atlantic Christian College in Wilson, North Carolina.

    Bryan has been a former member of the USP Biopharmaceutics Expert Committee and is presently a member of USP Expert Panels on Performance Verification Testing, Capsules, Performance Tests for Semisolid Dosage Forms and Solubility Criteria for Veterinary Drugs. He is a Steering Committee member of the AAPS In-Vitro Release Dissolution Testing (IVRDT) Community Leadership Team, co-founder and co-moderator of the Dissolution Discussion Group (DDG) and is a current member of the American Chemical Society.

  • Beverly Nickerson

  • Yan Wu, Ph.D.

    Yan Wu, PhD., Principal Scientist in Analytical Chemistry in Development and Supply at Merck with over 20 years of pharmaceutical industry experience. Past and current responsibilities include analytical lead on Integrated Development and Supply teams for development of drug products in late clinical stages and support of new product filing and launch activities; lead of Stability Project Management, Stability Sample and Data Management groups that were responsible for stability study design, execution, and filing for late stage development and commercialization of drug products; analytical development for drug substance throughout different clinical stages and new product launch. Served as 2018 AAPS Stability Focus Group (Stability Community) Chair; Active member of the IQ group focused on the Regulatory aspects of Risk Based Predictive Stability (RBPS).

August 16, 2022
Tue 1:30 PM EDT

Duration 2H 0M

Already Registered?
For Technical Support
(888) 705-6002
+1 (858) 201-4136*
*for callers residing outside of the United States