Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B

Join our experts, and by attending this forum, you will:

• Gain in-depth knowledge and engage in insightful discussions to deepen your understanding of ICH Q6B.
• Learn about the evolving regulatory landscape around biopharmaceutical specification settings, particularly under ICH Q6B.
• Understand current practices and key challenges in setting specifications for biopharmaceuticals.
• Stay ahead of industry trends with perspectives on patient-centric specifications and their future direction.

Event Overview

Part 1: Overview of ICH Q6B guideline and current practice on specification settings (23 April 2025)

We’ll discuss the latest revision of the ICH Q6B guideline on specification setting for biotechnological and biological products, including biologicals such as gene therapies and cell-based therapeutics. Additionally, we’ll introduce the basic regulatory science behind setting specifications for drug substances and products, including monoclonal antibodies and protein therapeutics. Key discussions will also cover analytical methods such as mass spectrometry and chromatography in setting specifications.

Determining Critical Quality Attributes (CQAs) for biopharmaceuticals is important. We’ll explore current practices for setting specifications, as well as the statistical considerations and analytical validation techniques involved in this process. We will also address how advanced data modeling is shaping the future of specifications in the evolving regulatory landscape.

Part 2: ICH Q6B & challenges in setting patient-centric specifications (30 April, 2025)

Several challenges exist when setting patient-centric specifications for biotherapeutic products. We’ll also explore the role of real-world evidence (RWE) and patient-reported outcomes (PROs) in shaping these specifications. In addition, we will discuss strategies for establishing patient-centric commercial specifications and the importance of patient-specific quality standards, as demonstrated through case studies on monoclonal antibodies, gene therapies, and CAR-T cell therapies.

What you need to know:

Part 1: 23 April, 2025

Part 2: 30 April, 2025

Each day has a dual-time broadcast, with starting times as follows:

• Broadcast #1: 09:00 h GMT (London) / 10:00 h CET (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
• Broadcast #2: 08:00 h PST (Los Angeles) / 11:00 h EST (New York) / 16:00 h GMT (London) / 17:00 h CET (Paris/Berlin)

Duration: Approximately 60 – 90 minutes, incl. Q&A.

• Registrants attending this online event’s live broadcast sessions will receive a ‘Certificate of Attendance’.
• Join the BioQC user community for ongoing discussions after the event.

Who should attend?

Anyone interested in setting specifications for biotechnological and biological products. This event provides an overview of current practice as well as the shifting regulatory landscape on ICH guideline Q6B.

• Industry experts involved in process and product development
• Industry experts engaged in compliance and analytical method lifecycle management
• Quality control/quality assurance personnel
• Regulatory affairs professionals
• Academics interested in learning about specification settings and the regulatory requirements in the pharmaceutical and biopharmaceutical industry

Presenters / Panellists

Dr. Patanachai “Kong” Limpikirati
Lecturer, Department of Food and Pharmaceutical Chemistry
Faculty of Pharmaceutical Sciences, Chulalongkorn University (Thailand)

Carmilia Jiménez Ramírez, Ph.D.
President & Chief Consultant
Miliar Biopharma Solutions (USA)

Dr. Eric Rozet
GSK (Belgium)
Director of Statistics

Simona Cianetti
GSK (Italy)
Senior Director, Global Product Analytics and CMC Statistics

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.

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