The transition from early phase to late phase of a small molecule program plays a pivotal role in determining a program’s ultimate success. Early planning strategies can help minimize the burdens often faced in that transition. The implementation of modeling tools to analyze the relationships between material attributes, process parameters and product performance can provide an enhanced understanding of the drug product and improve manufacturing efficiency. In this webinar, experts will demonstrate how Catalent’s (multivariate) modeling tools can help understand the relationship between material Critical Material Attributes (CMAs), unit operation Critical Process Parameters (CPPs) and their impact on the finished dosage. In addition, the experts will explain how these approaches can facilitate in the tech transfer of a program. Lastly, this webinar will feature an overview of Catalent’s oral solid dose turnkey solutions featuring advanced oral solid dosage (OSD) manufacturing technologies and expertise throughout an extensive global network.

Key Learning Objectives:

  • Key Considerations for Tech Transfer
  • Identification of critical material attributes (CMA), critical process parameter (CPP) and critical quality attributes (CQA) of drug product and how to predict their impact on a formulation and manufacturing processes
  • Overview of primary processing technology in OSD manufacturing and how material characteristics dictate the unit operations method.
  • Overview of Catalent’s Manufacturing Solutions

Featured Speakers

Dr. Uwe Hanenberg

Director, Product Development
Catalent

Dr. Uwe Hanenberg studied Pharmacy at the University of Marburg between 1987 and 1991. In 1997 he received his PhD in Pharmaceutical Chemistry. Uwe has 20+ years of experience in the pharmaceutical industry with Bayer, Altana Pharma, Grünenthal and Catalent in roles within Quality, Product Development, Operations, Project Management and Science & Technology, always in relation to oral solid drug development, manufacturing and packaging.

Dr. Dejan Lamesic

PD Scientific Team Leader
Catalent

Dejan is a pharmacist by profession, with a PhD in the field of pharmaceutical technology focusing on Quality by Design aspects of pharmaceutical excipients for development and manufacturing of solid dosage forms. In 2018 he joined Catalent Pharma Solutions, where he is currently leading a Product Development Team in Schorndorf, Germany, focusing mainly on late stage development of immediate and controlled release solid dosage forms for various clinical and market introduction phases.

Dr. Günter Nykamp

Consultant
Bensmann GmbH

Dr. Nykamp has extensive expertise in the areas of drug development, production, product transfer and regulatory affairs, the optimization of production processes, contract manufacturing and development, as well as in pharmaceutical operations. After more than 15 years in various management positions in the pharmaceutical industry, Dr. Nykamp joined Bensmann GmbH.

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