Course Overview

The objective when conducting comparability studies is to confirm that the quality, safety, and efficacy of the drug product remain intact following changes to the manufacturing process. While providing the essential linkage with clinical materials utilised at different points in the drug development cycle. There is a critical need to understand the product in terms of mechanism of action, Target Product Profile and Critical Quality Attributes. The aim is to develop a fingerprint or defined product identity which then can be used to drive the Analytical Target Profile (ATP) as well as the overarching control strategy for managing the lifecycle of the product, process and analytical methods. Underpinning this approach is the uses of comparability studies to link the different phases of drug development and provide the continuity of scientific knowledge and understanding.

This course is designed to position comparability studies as a vital tool in developing biopharmaceutical products. Participants will gain in-depth knowledge of enhanced process development and quality risk management as outlined in ICH quality guidelines.

A central focus of the course is to build a robust product and process profile, enabling the enhancement of the process development efforts and facilitating regulatory compliance. This foundation supports comparability studies throughout the product lifecycle, serving as structured milestones that guide each phase of development. Participants will learn strategies to effectively manage the inevitable changes in product and process while minimising potential quality and regulatory risks. Ultimately, the course equips professionals to streamline development, achieving rapid, first-time-right outcomes that meet high-quality standards and regulatory expectations.

Learn more about how we deliver live online training.

Key Learning Objectives

• Understand ICH quality guidelines and principles in relation to comparability studies
• Appreciate the critical role of comparability studies in maintaining product quality, safety, and efficacy through manufacturing process changes
• Learn to apply risk management and change control tools
• Develop phase-appropriate comparability studies throughout the product lifecycle to future-proof product development
• Learn to integrate PPQ studies with commercial manufacturing processes and develop control strategies to support successful regulatory submissions (BLA/MAA)
• Capture and manage comparability data throughout the product lifecycle, from inception to discontinuation
• Apply the comparability approach to facilitate efficient, first-time-right product development

Who Should Attend?

This course is aimed at professionals involved in CMC for biologics, specifically comparability activities. These include:

• Process development scientists and professionals
• Upstream process scientists and professionals
• CMC development program managers
• CMC project managers
• Quality Assurance professionals
• Regulatory Affairs professionals

Format, Dates & Times

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

2 & 3 June 2026

7-Hour Course Delivered Over 2-Days

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18 & 19 November 2026

7-Hour Course Delivered Over 2-Days

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Course Times

For live online delivery, both sessions start at 1:00 PM (UK time) and finishes at 4:00/4:30 PM (UK time).

Group Discount

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

For more information, complete our contact form by following the link. Get in touch.