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Mastering Comparability Studies for Biopharmaceutical Development and lifecycle Management

24 & 25 June 2025 | Short Online Course

Original price was: £595.00.Current price is: £476.00.

2-day Live Online Training 

Empower your biopharmaceutical development with essential comparability study skills to ensure quality, compliance, and streamlined regulatory approval.

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

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.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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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

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Course Dates

 

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

24 & 25 June 2025

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

4 & 5 November 2025

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

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.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

 

Course Outline

Course Information

  • The course begins at the time stated below
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Session 1 | Day 1

24 June 2025

4 November 2025

 

210 mins | 1:00 PM UK

Introduction to ICH Quality Guidelines

  • Overview of key ICH guidelines and principles in quality management
  • Developing an enhanced target product profile (TPP) aligned with ICH standards

Understanding Product Comparability

  • Importance of comparability studies and the critical role of ICH Q5E and other ICH guidelines
  • Consideration of biosimilars and their impact on comparability requirements

Risk Management and Quality Assurance Tools

  • Using ICH-defined tools to enhance risk management and change control processes
  • Approaches for ensuring robust product quality throughout development stages

Linking Target Product Profile to Process Understanding

  • Establishing critical process parameters (CPPs) and process control strategies early in development
  • The connection between enhanced TPP and process understanding for improved outcomes

Case studies 

  • Along with the presentation, examples and case studies will be provided.
Session 2 | Day 2

25 June 2025

5 November 2025

 

210 mins | 1:00 PM UK

Analytical Approaches for Quality Evaluation

  • Science- and risk-based approaches for developing and maintaining analytical procedures
  • Evaluating the quality of drug substances and products during various development phases

Phase-Appropriate Product Comparability

  • Lifecycle approach to comparability studies, from early stages through to market readiness
  • Conducting phase-appropriate studies to future-proof product development efforts

Process Performance Qualification and Commercial Strategy

  • Integrating process performance qualification (PPQ) studies with commercial manufacturing processes
  • Developing control strategies to support successful BLA/MAA submissions

Lifecycle Management and Knowledge Integration

  • Capturing and managing comparability data throughout the product lifecycle
  • Emphasising knowledge management from product inception through to discontinuation for sustained quality and compliance

Case studies 

  • Along with the presentation, examples and case studies will be provided.

Richard Francis is a seasoned biopharmaceutical professional with over 43 years of experience across leading organisations such as Celltech, GSK, Centocor, and Mereo Biopharma. A recognised expert in Chemistry, Manufacturing, and Controls (CMC), Richard has led process development, manufacturing operations, and regulatory approvals for numerous biopharmaceutical products, including monoclonal antibodies, antibody-drug conjugates, and cell and gene therapies.

 

As a senior executive, Richard has driven global CMC and quality strategies, managed regulatory submissions, and facilitated successful product approvals, including Caplacizumab, the first nanobody therapy. He has a proven track record in developing innovative manufacturing processes, analytical methods, and technology transfers. Richard’s leadership extends to academia, as an honorary lecturer at University College London, and he has co-led industry training programmes on Quality by Design (QbD) and process qualification.

 

Richard also founded Francis Biopharma Ltd, providing consultancy services to global biopharma companies on manufacturing scale-up, regulatory compliance, and process development. His contributions to biopharmaceutical science are reflected in over 50 publications and his active participation in academic and industry panels.

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

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24 & 25 June 2025 | Short Online Course

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