Dissolution Qualification – the PQ vs. MQ debate: What’s Right for Your Lab?

You have the choice. PQ or MQ? What do you go with? Today all models exist in the labs from 100% PQ to 100% MQ. Some companies have a hybrid approach and also the frequency of the MQs can vary. The discussion will highlight some advantages and disadvantages of both approaches and give you some insights on which approach could work best for your lab.

Presenter: Karen Krauel-Göllner, PhD (Product Manager Dissolution, Agilent Technologies, Inc.)

Karen Krauel-Göllner is a registered pharmacist and holds a PhD in Pharmacy from the University of Otago, New Zealand. Karen has worked in various roles in the field of pharmaceutical development. For the last 5 years she has been working with Agilent Technologies and currently holds a position as product manager for dissolution systems.

Presenter: Ken Boda (Dissolution Product Specialist, Agilent Technologies, Inc.)

Ken joined Varian (now Agilent) in 2005 as an Applications Engineer and is now a Dissolution Product Specialist. Prior to working at Agilent, he worked in pharma specializing in dissolution testing and method development. As a Dissolution Product Specialist, Ken works with customers in determining the best systems for their needs and optimizing their work flows. He has also helped educate customers on dissolution science through webinars, the Dissolution Discussion Group, LinkedIn, and other channels.

Presenter: Bryan Crist (President, DissoAssist Consulting)

Bryan is currently the president of DissoAssist consulting based in Wilmington, NC since 2021. 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. His activities from 1997 until 2021 had 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. Prior to 1997, Bryan performed analytical testing, supervised, and managed pharmaceutical laboratories with Bristol-Myers Squibb, Merck, AAI and Abbott Laboratories until he joined the dissolution equipment manufacturer VanKel.

Bryan has developed and routinely conducts numerous seminars related to dissolution and drug release testing. He’s provided 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 several USP Expert Panels on Performance Verification Testing, Capsules, Performance Tests for Semisolid Dosage Forms and Solubility Criteria for Veterinary Drugs. He’s 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.

Presenter: Vivian Gray (Founder VA Gray Consulting; Managing Director of Dissolution Technologies)

Vivian has spent the last 40+ years involved in all aspects of dissolution testing and evaluating new dissolution technology. At the United States Pharmacopeia, she enjoyed a long career serving first as a bench chemist, supervisor and lastly as a liaison to various expert USP committees, including the Biopharmaceutics and Dissolution Expert Committee. In 1997, Vivian joined the DuPont-Merck Pharmaceuticals Company Analytical Research and Development Section as the Head of the Dissolution Group.

Vivian has been an invited speaker for conferences on 70 occasions (28 of these were international invitations), lecturing especially in the areas of dissolution method development and validation, FDA requirements in dissolution testing, troubleshooting dissolution method problems, and new dissolution technology and dosage forms. She is a proactive participant in the field as demonstrated by 54 publications, including 6 book chapters. Vivian has co-authored a book on dissolution testing called “Handbook of Dissolution Testing”, Third Edition, published in 2004.