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Topic

Advanced in vitro methods in generic drug product development

Description

The use of Pion equipment within Zentiva development will be presented. Zentiva is a generic company and thus applications for the development of generics will be discussed.

Topics covered:

• Physicochemical characterization of APIs using T3
• Screening of API solid forms using InForm
• Precipitation experiments on InForm – screening of precipitation inhibitors and description of factors influencing repeatability of the experiments
• MacroFlux – indirect identification of API-excipient interactions and risk mitigation for bioequivalence studies
• Rainbow fiberoptic system – use for precipitating systems, comparison with standard offline analysis (UV/HPLC)

Time

Nov 10, 2022 11:00 AM in Eastern Time (US and Canada)

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Message preview	Hi there, You are invited to a Zoom webinar. When: Nov 10, 2022 11:00 AM Eastern Time (US and Canada) Topic: Advanced in vitro methods in generic drug product development Register in advance for this webinar: https://us06web.zoom.us/webinar/register/WN_uorzyxySRCqh7ukdZMGDfQ After registering, you will receive a confirmation email containing information about joining the webinar. ---------- Webinar Speakers Josef Beránek, Ph.D. (Scientific Group Leader @Zentiva) Josef Beranek has worked for Zentiva since 2011. He currently leads the Preformulation and Biopharmacy unit within Zentiva R&D. He is involved in a variety of drug development projects, contributes into the selection and characterization of alternative solid form of active substance and is engaged in selection and optimization of prototypes for clinical studies. He is also responsible for development of innovative dissolution approaches, pharmacokinetic modelling and collaboration with external partners and universities. In 2005 Josef received a master degree in biochemistry and biotechnology from the University of Chemical Technology in Prague, Czech Republic. In 2010 he finished a PhD in chemistry from the University of North Dakota, USA for his work in analytical and environmental chemistry. He then worked as a postdoctoral researcher at Pacific Northwest National Laboratories, Richland, Washington, USA in the group of chemical physics and analysis. Ing. Tereza Krejčí (Preformulation and Biopharmacy specialist in Zentiva @Zentiva Czech Republic) Tereza Krejčí works as a Preformulation and Biopharmacy specialist in Zentiva, Czech Republic. In her role, she is responsible for physicochemical characterization of APIs, early-stage preformulation experiments, solubility and dissolution experiments, and their correlation with clinical trials. An important part of her job is risk mitigation before bioequivalence studies and prediction of their outcome. Tereza holds a Master's degree in analytical chemistry (program Drug analysis) and she studied Ph.D. at UCT Prague (program Drugs and Biomaterials) under the supervision of prof. František Štěpánek. As a member of The Parc (Pharmaceutical Applied Research Center), she also worked closely with the industrial experts from Zentiva throughout her studies. In her research, she focuses on in vitro characterization of bio-enabling formulations as well as on their rational design.

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