Introduction to CMC Analytics for Biologics, Cell & Gene and Biosimilars

Coming Soon | 2-Day Live Online Course

The price is for all 2-days 

Examine Phase-Appropriate Regulatory, Technical and Quality Elements for Characterisation, Comparability, and Control Strategies

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Course Overview


Biological therapeutics and vaccine products require an array of analytical methods to characterise their biomolecular structure and biological functions. The CMC elements needed to support product safety and efficacy are defined in a diverse array of regional and global regulatory guidances. The molecular complexity of each biological product dictates the analytical technologies necessary for its characterisation, comparability, and control strategies. But all biological product modalities require similar types of CMC analytical studies and key analytical data sets during development.


This introduction to CMC analytics for biologics, cell & gene and biosimilars course will provide you with a comprehensive overview of the phase-appropriate analytical expectations for biological products of any type (novel or biosimilar protein therapeutics, well-characterised or classic vaccines, advanced cell or gene therapies). Once completed, you will understand which analytical studies are needed, why they are important, and where to find technical guidance for your specific product modality. You will learn the most common mistakes made in method lifecycle elements, reference standard management, stability programs and comparability studies, and how to avoid them, especially under highly accelerated CMC timelines.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

What is Included in a Live Online Course?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download and file
Register For Free Online Session


There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Key Learning Objectives


  • Learn which CMC analytical data packages are required for all biotech and cell & gene products, and why.
  • Discover where the ‘rules’ for biological products are written in regulatory and compliance documents.
  • Review critical ICH Guidelines such as ICH Q5A, ICH Q5B, ICH Q5C, ICH Q5D, ICH Q5E, ICH Q6B.
  • Examine phase-appropriate considerations for qualification/validation/verification of methods.
  • How should product reference standards be established, monitored, and bridged over time?
  • Understand the analytical considerations for biological/cell & gene product release and stability specifications.
  • Identify the most challenging elements of analytical comparability studies.
  • How to find analytical information on traditional, biosimilar, or cell & gene products?
  • Review the specific challenges and opportunities when using, or being, a CRO analytical lab.

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges
Introductory Module 1

FREE to Attend | Live & Recorded

Introduction to CMC analytics for biologic, cell & gene, vaccine and biosimilar products

  • Introduction to CMC analytics
  • Overview of the challenges during development and manufacturing
  • Highlight important guidelines you should be aware of
Day 1

DD MMM 2023 | Session 1 |  120 mins | 13:00 PM UK

Current CMC regulatory requirements and hot-button issues for biological and cell & gene products

  • Why do biological product CMC requirements differ from those of chemical products?
  • Why are there different safety concerns about biological product and process related impurities?
  • Which specific worldwide regulations detail CMC study requirements for biological and cell & gene products?
  • What are the relevant ICH Guidelines such as ICH Q5A, ICH Q5B, ICH Q5C, ICH Q5D, ICH Q5E, ICH Q6B.
  • What CMC analytical data packages are required for regulatory approval of all biological and cell & gene products?
  • When should these CMC studies be done during the product development lifecycle?
  • How are these CMC studies impacted by accelerated clinical programs?
  • Which of these CMC data are generated in GMP vs R&D labs?
  • What is the risk of CMC data generated by non-GMP AD/PD R&D labs?
  • What are commonly implemented quality practices for CMC AD/PD R&D labs?

DD MMM 2023 | Session 2 |  120 mins | 3:15 PM UK

Phase-appropriate analytical method lifecycle expectations for biological and cell & gene products

  • What is the difference between method qualification and method validation?
  • When is a method qualification acceptable, and when is a method validation necessary?
  • What is required for the verification of compendial methods?
  • What are the most important elements a correct method qualification/ verification/validation study?
  • Which method validation parameters are usually designed incorrectly for biological and cell & gene products?
  • What are the requirements when making changes in analytical methods at any phase?
  • What are the key elements of method tech transfer studies (changing from lab A to lab B)?
  • What are the key elements of method bridging studies (changing from method A to method B)?
  • How are changes staged for methods being used in stability protocols?
  • What are key considerations when using contract testing laboratories for analytical methods?
Day 2

DD MMM 2023 | Session 1 |  120 mins | 13:00 PM UK

Specifications, reference standards, and critical assay reagents

  • What are the key characteristics of any biological and cell & gene products that require control and consistency?
  • Where can you find the analytical methods currently being used for various biological and cell & gene products?
  • What four critical elements are needed for the establishment of meaningful, reliable specifications?
  • What are some of the types and uses of biological reference standards and materials?
  • What is the tiered approach to biological product reference standards?
  • What are the critical elements of bridging biotech physiochemical vs potency reference standards?
  • What are the current expectations for characterisation, comparability, and control of HCPs?
  • Which process impurity reference standards are required for recombinantly-expressed products?
  • How should critical reagents/materials be managed to better assure consistent method performance?

DD MMM 2023 | Session 2 | 120 mins | 13:00 PM UK

Phase-appropriate stability and comparability requirements for biological and cell & gene products

  • What are the phase-specific requirements for biological and cell & gene product stability studies?
  • How is the stability-indicating profile of a biotech product experimentally established?
  • What data are required in the validation of stability-indicating methods?
  • Why are stability data the main indicator of performance variability in validated methods?
  • What are the critical logistical elements of a stability protocol at any phase of development?
  • What are target, accelerated, stressed and forced conditions for biological and cell & gene products?
  • Why can’t biological and cell & gene product shelf life be extrapolated from accelerated stability data?
  • What is the core paradigm to follow when making changes to biological processes?
  • What is the tiered approach to comparability studies for biological products?
  • What are the important procedural elements of an analytical comparability study?
  • How do comparability studies change relative to the phase of product development?

Olivier Negre, PhD

Olivier developed his expertise in preclinical research and translational science through more than 20 years of experience in biotherapies.


After working at Inserm on macrophages and at Bioprotein Technologies on vaccines, he joined bluebird bio (formerly Genetix Pharm) to develop gene therapies. He was R&D team leader for 10 years in Paris and Director preclinical & translational research for 5 years in Cambridge MA, USA. He contributed to the development of the first approved gene therapy for beta-thalassemia (Zynteglo), from preclinical studies to clinical trials and marketing authorization.


In 2019, Olivier participated in founding Biotherapy Partners to foster drug developments in the field of cell and gene therapies. He is currently board member of the French Society and Gene and Cell Therapy, Co-President of the think tank Gene and Cell Therapy Institute in Paris, Head of R&D of a biotech company and Partner at Biotherapy Partners.


He contributed to several patents and scientific publications in the field of gene and cell therapy (Nature 2010, Blood 2011, Stem Cells 2013, Current Gene Therapy 2015, Human Gene Therapy 2016, New England Journal of Medicine 2017, New England Journal of Medicine 2018, Science Translational 2019, Molecular Therapy Methods & Clin Dev 2020, BioDrugs 2020, New England Journal of Medicine 2021). Olivier graduated from ENSTBB engineering school in Bordeaux and earned a PhD in cell and molecular biology from Paris 7 University.


Olivier has delivered many courses on cell and gene therapies and is fully versed in how they are developed and manufactured. When delivering training courses, he can draw upon his extensive experience and knowledge, supporting delegates with examples and case studies.


This course provides a comprehensive overview of CGT. It is aimed at technical professionals who are either new to the industry or thinking about a career move into CGT. If you are a someone with experience in small molecules or biologics this course is will suit you.


These include:

  • Regulatory Affairs Professionals
  • Production Personnel/Technicians
  • Quality Professionals
  • Clinical Professionals
  • Process Development
  • Personnel
  • Scientists involved in Development
Free First Module and Pricing
  • Free First Module and Pricing
  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the course overview.


Frequently asked questions (FAQs)

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate