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Starts 18 May 2020
Online Academy,
6 module series over 4 weeks

Product Specifications, Stability, Comparability and Similarity for CMC Analytical Studies

Learn best practices for ensuring the quality and efficacy of your products on this online course.

Course 3/3 of the Biopharmaceutical and Biosimilar CMC Analytical and Lab Quality Series - Discover the key regulatory, technical and quality elements

In light of recent developments

If you would like to start the course sooner than advertised please contact us and we will arrange this for you as soon as possible.

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.

What will you learn?

Shelf life

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

Key differences

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

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

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

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.


Purchase a place on all 3 online academies in the series and receive the final place at half price, saving you a total of £440 + VAT. Attending all 3 courses will provide you with a complete understanding of the regulatory, technical and quality requirements for CMC analytical studies.

To take advantage of this offer please get in touch with our training consultants at or call +44 (0)20 7551 9521. 

Methods and Reference Standards for CMC Analytical Studies

Gain a comprehensive understanding of technical standards for CMC analytical studies

Find out more
Regulatory and Compliance Requirements for CMC Analytical Studies

Discover key regulatory requirements for CMC analytical studies to ensure global compliance

Find out more

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.