This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.


2-3 November 2020
Radisson Blu Edwardian Grafton Hotel,

Comparability for Biologics

Gain an understanding of regulatory and technical considerations to help you manage process change in the manufacture of biologics

Book with earlybird pricing now!

Receive £100 off if you book before 2 September 2020

Course Overview

Process changes made during the manufacture of recombinant proteins can have profound implications. This 2-day course provides valuable insight into the quality, safety, efficacy and regulatory impact of manufacturing changes and how to manage process change to guarantee regulatory compliance and product consistency at all times. 

It features numerous case studies from industry and practical advice from our experienced professionals on the best ways to satisfy the needs of the regulators. You will also learn how various process changes may impact the success of your products.

What will you learn?

Process change

Gain insight into the inter-relationship between process change, quality, safety and efficacy - you will discuss the potential significance of various process changes and how these may impact the quality of your products


Examine the importance of change control, Good Manufacturing Practice (GMP) and the potential of Process Analytical Technology (PAT)

Analytical tools

Understand the physicochemical and biological analytical tools available to monitor the impact of process change

Testing programmes

Hear about the non-clinical and clinical testing programmes that might be required to support major process change

Regulatory requirements

Analyse the US and EU regulatory requirements following process change

Who is this course for?

This course is suitable for anyone working in:

  • Manufacturing
  • Analytics
  • Regulatory affairs
  • Quality assurance
  • Project managers

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

Get the latest event updates

Sign up to get the latest event updates and information.