Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development

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Part 1: Overview of the ICH Q14 GuidelineICH Q14 Analytical Procedure Development by Dr. Christof Finkler

Part 1: Overview of the ICH Q14 GuidelineExpert Forum Panel Discussion

Part 2: Key Challenges and Solutions in Implementing ICH Q14Analytical Quality by Design: from Quality Target Product Profile to the Analytical Target Profile by Prof. Sandra Furlanetto

Part 2: Key Challenges and Solutions in Implementing ICH Q14Critical Analytical Procedure Parameters and Risk Assessments by Dr. Cyrille Chéry

Part 2: Key Challenges and Solutions in Implementing ICH Q14Analytical Procedure Control Strategy (ACPS) by Dr. Lars Geurink

Part 2: Key Challenges and Solutions in Implementing ICH Q14Expert Forum Panel Discussion

Presenters / Panellists

Dr. Christof Finkler Senior Director, CMC Policy - Technical Development Biotech F. Hoffmann-La Roche AG (Switzerland) Dr. Christof Finkler is the Senior Director of CMC Policy within Technical Development Biotech at Roche and also acts as a senior technical advisor within Roche’s biotech development. In his previous role as Site Head of Analytical Development and Quality Control Biochemistry at Roche’s headquarters in Basel, Switzerland, he was responsible for establishing new analytical technologies, protein characterisation, and the development and validation of analytical methods, as well as the quality control of investigational medicinal products and the transfer of analytics to the commercial QC units. In addition to his extensive knowledge in the field of analytics, Christof is an expert in QbD for product and process development and has led Roche’s QbD initiative. Christof serves as the EFPIA topic lead for analytical lifecycle management and is a member of the ICHQ2/Q14 expert working group/implementation working group and the EFPIA ICHQ1/Q5C support team. He is also a member of the CASSS Board of Directors, serves as a board member of the IQ Consortium, and is part of the board of the Analytical Science division of the Swiss Chemical Society.

Prof. Sandra Furlanetto Professor of Analytical Chemistry University of Florence (Italy) Prof. Sandra Furlanetto holds a PhD in Pharmaceutical Chemistry and is a Full Professor of Analytical Chemistry at the University of Florence. She serves as the Editor of the Journal of Pharmaceutical and Biomedical Analysis and is a member of the Italian National University Council. From 2011 to 2021, she acted as the Rector’s Delegate for student guidance at the University of Florence. She has made significant contributions to the dissemination, both nationally and internationally, of the role played by multivariate strategies in analytical chemistry and pharmaceutical technology. She is an expert in applying QbD and AQbD to ensure the quality of analytical processes and pharmaceutical products.

Dr. Cyrille Chéry Associate Director UCB (Belgium) Dr. Cyrille Chéry is the Associate Director at UCB, a Belgian pharmaceutical company. He leads the team responsible for developing and validating analytical methods for controlling drug substances and drug products (NCEs and antibodies). These methods utilise physicochemical principles, such as mass spectrometry. He holds a PhD (2004) in analytical chemistry from the University of Ghent, Belgium, and a Master of Science (1997) from the University of Bordeaux. Before joining UCB in 2012, he held various positions in analytical chemistry at MSD/Merck, focusing on small molecules (new chemical entities). He is the author of papers on inductively coupled plasma-mass spectrometry and on analytical quality by design.

Dr. Lars Geurink Associate Director Assay Development Batavia Biosciences (Netherlands) Dr. Lars Geurink is the Associate Director of Assay Development at Batavia Biosciences. Intrigued by biotechnology, immunology, and neuroscience, as well as being passionate about developing biotech products, Lars studied life sciences and technology at Universiteit Leiden and Technische Universiteit Delft. He earned his PhD from Uppsala Universitet, focusing on analytical quality by design (AQbD) for vaccine characterisation. Prior to joining Batavia Biosciences, Lars worked at Janssen Vaccines, where he served as team manager for analytical development and gained experience in analytical strategies for vaccine testing and implemented AQbD and provided analytical solutions for a new RNA vaccine platform. As Technical Lead at Batavia Biosciences, Lars deepened his expertise in biotech products, processes, and the biopharmaceutical lifecycle.

Moderators

Prof. Dr. Cari Sänger-van de Griend Expert in (bio)pharmaceutical analytical chemistry with 30 years of industrial and academic experience in method development and control strategies, including Analytical Quality by Design (AQbD), and focused on best practices and knowledge sharing.

Dr. Ewoud van Tricht Expert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.