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.

Starting TBC in 2021

4-week online academy

Learn best practices for ensuring the quality and efficacy of your products

Course 3/3 of the Biopharmaceutical and Biosimilar CMC Analytical and Lab Quality Series

Course Overview

The final course in the online biopharmaceutical and biosimilar CMC analytical series. This course follows on from course 1 on regulatory challenges and course 2 on methods and reference standards. Learn more about the series here.

Part of Bioprocess International Academy's new online biopharma/biosimilar CMC analytical series this course has been designed to provide you with a complete understanding of biotech stability and comparability studies. Both studies are crucial for biopharmaceutical and biosimilar development and this 4-week course will provide you with the knowledge and competency to establish and execute both study programs. 

The course will help you identify protein stability profiles, through the comparability element will provide you with experimental design tips to help you overcome the challenges when developing biopharma/biosimilar products.

Online Academies

BioProcess International Academy online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 4 weeks students will learn through:

  • 6 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact

What will you learn?

Shelf life
Shelf life

Examine how to determine the shelf life of a biotech protein product

Key differences
Key differences

Identify the key differences between biologics and small molecules, and examine the difference between comparability and similarity 

Protein stability programs
Protein stability programs

Learn best practice to establish and execute protein stability programs and discover how to determine the stability indicating profile of a biotech

Analytical comparability
Analytical comparability

Assess analytical comparability throughout development for both innovator and biosimilar and understand which analytical methods to use in comparability studies

Overcome challenges
Overcome challenges

Gain an insight into common concerns raised during inspections and identify the common mistakes made during comparability studies

Who is this course for?

This course is primarily aimed at professionals working in biopharmaceutical analytical CMC (CMC biologics). The materials are also appropriate for regulatory, project management and bioprocess professionals wanting to broaden their knowledge in CMC biologics.

Find out more about online courses...

BioProcess International Academy online courses are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

On average, delegates of our online academies said...

for quality of content
applied content during the course to their role
for quality of delivery

25% discount on Routledge books

As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website

Examples of books and eBooks within biopharmaceuticals include:

  • Fundamentals of Modern Bioprocessing
  • Cell Culture Bioprocess Engineering, Second Edition
  • PAT Applied in Biopharmaceutical Process Development and Manufacturing
  • Process Validation in Manufacturing of Biopharmaceuticals
  • Immune Aspects of Biopharmaceutical and Nanomedicines
  • Mathematical and Statistical Skills in the Biopharmaceutical Industry
  • And more

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.