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.

Informa

New dates TBC
LIVE Online Academy,
3 sessions delivered across 2 weeks

Introductory CMC Analytical Studies and Lab Quality Practices

Gain an understanding of the practical requirements for biopharm CMC studies to support strategic decisions, budgets and timeframes

For biotech and biosimilar products

Live Online Academies

In light of the uncertain times we’re facing at the moment, gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. 

Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

Course overview

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, including biosimilar products. Key deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, and strategies for preventing (or remediating) gaps will be presented.

What will you learn?

Phase-specific requirements

Gain a comprehensive overview of the phase-specific requirements for CMC analytical characterisation, comparability, release and stability of biotechnology products

Product life cycle

Examine the different stages of the life cycle including pre-clinical, clinical trials, commercialisation and post-approval

Analytical considerations

Discuss analytical considerations for a wide variety of biopharmaceuticals including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates)

Product reference standards

Maintain product reference standards and design successful comparability tests

Comparability tests

Design and implement successful comparability tests for biosimilars

Product specifications

Learn to set meaningful product specifications, conduct forced degradation studies and manage tech transfer

Methods and protocol

Bridge changes in analytical methods and generate effective stability protocols

Lab quality practices

Assess critical elements of laboratory quality practices that significantly impact the reliability of test data from R&D through to current GMP will be illustrated

Who is this course for?

This training course is intended for professionals who are involved with stability testing for biotechnology products, directly or indirectly. Professionals from Pharmaceutical, Biotechnology, Drug Delivery and Medical Device companies should attend, such as, but not limited to:

  •  Stability Directors/ Supervisors/Managers/Analysts/Coordinators
  • Laboratory Supervisors/ Managers
  • Project Managers/Coordinators
  • Quality Control Analytical Chemists
  • Research and Development Chemists
  • Biostatisticians
  • LIMS Administrators
  • QA/QC Reviewers
  • Validation Scientists
  • Calibration/Metrology Groups
  • Internal or Independent Auditors
  • Manufacturing/Production Managers

The analytical side of CMC with course leader, Nadine Ritter


Nadine Ritter, President and Analytical Advisor at Global Biotech Experts, discusses how shortening timelines are impacting the analytical side of chemistry, manufacturing, and control (CMC).

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.

Digital Training Guide

Compare online learning options in the digital training guide to find out which is the right study mode for you, or your team.