Performance Verification Testing in Dissolution

Dissolution testing measures the extent and rate of solution formation from a drug dosage form, such as tablet, capsule, or ointment. Understanding the dissolution of a drug allows us to learn about bioavailability and therapeutic effectiveness. In this webinar, Naiffer Romero from the USP will highlight recent changes and benefits on the general chapter <711> related the Dissolution Performance Verification Standard. Then Ben Calvopina from Sotax will share the results of a study demonstrating the automation of the dissolution testing process with samples requiring a UV finish or a HPLC finish.

Key Learning Objectives

• Learn about the benefits of the new standard on Dissolution Performance Verification
• Explore the implementation and benefits of automation in dissolution testing
• Discover on-line dissolution workflows with HPLC

Who should attend

Scientists involved with dissolution testing

Presenter: Naiffer Romero, MSc, MPH (Principal Scientist - Scientific Affairs, US Pharmacopeia)

Naiffer has more than 20 years of pharmaceutical industry experience. In his 13+ years tenure with USP, he has served several roles: Lead scientist in the dosage form performance laboratory, reference standard development team, Manager in charge of LATAM Compendial engagement and education, responsible for stakeholders and national regulatory bodies engagement. Naiffer is also a certified USP Education instructor. Most recently, Naiffer joined USP's Scientific Affairs performance cell, where he leads scientific outreach and engagement for LATAM & U.S. on key national health priority topics. His combined pharmaceutical expertise includes Analytical Development, salt and polymorph selection, Development of dissolution methods, IVIVC modeling, and impurity analytical strategy. Naiffer also serves as a member of USP's Nitrosamine Steering Committee and community host to 'Nitrosamine Exchange,' a knowledge community in All-things Nitrosamine. Naiffer also liaises technical discussion on pharmacopeial collaboration, including international meetings of World Pharmacopeias (part of WHO).

Presenter: Ben Calvopina (Application Scientist and Dissolution Product Leader, SOTAX Corporation)

Ben is an Application Scientist and Product Leader for Dissolution at SOTAX's Westborough, MA facility. After receiving his degree in Physics from Marquette University, Ben taught Physics, Chemistry, and Computer Science at the Milwaukee School of the Arts. He joined SOTAX, where he's been for the last six years as the lead Service Engineer for some of the largest automated pharmaceutical laboratories in the Americas, leading all installation, qualification, and user training programs. He now resides in Massachusetts and works at SOTAX North American HQ in Westborough. He is responsible for all dissolution products and regularly conducts studies for SOTAX cGMP Pharma Services branch, including method development and validation of automated procedures. Ben actively participates in the USP collaborative study on the Dissolution Performance Verification Standard and is a participant in the AAPS IVRDT Leadership Team Meetings.

Panelist: Chantel Lee (Product Marketing Manager, Small Molecule Core Solutions – QAQC, Waters Corporation)

Chantel is a Principal Product Marketing Manager at Waters Corporation, where she manages marketing strategies and initiatives for HPLC products. She brings over ten years of experience in analytical chemistry, specializing in chromatography and Empower software and supporting customers from pharmaceutical, food, and chemical industries. Since joining Waters in 2017, Chantel has progressed through roles in technical support, business development, and marketing. She holds an MBA from Boston University along with an MSc in Analytical Chemistry from the University of Alberta, Canada.

Moderated by: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)

Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.