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CMC Analytical Comparability: Methods & Strategies for Biologics

  • 11 – 12 February 2026
  • Vienna, Austria | Online Live Stream | 9:00 CET – 17:30 CET
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Online Live Stream

CMC Analytical Comparability: Methods & Strategies for Biologics

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Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer

Case studies from the trainer's experience
Certificate of completion issued by the trainer
Comprehensive course documentation
Fully online

All sessions of this unique course also online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

meet the training leaders
Johannes Buchner | Fleming
Prof. Dr. Johannes Buchner
Dept. Of Chemistry
Technische Universität München, Germany
View trainer bio
Robert Zoubek | Fleming
Linkedin
Dr. Robert E. Zoubek
Executive Consultant
Granzer Regulatory Consulting & Services, Germany
View trainer bio
Thomas Ludwig | Speaker | Fleming
Thomas Ludwig MSc
Technical Lead – Cell-based Assays
VelaLabs GmbH
View trainer bio
Andre Abts | Trainer | Fleming
Linkedin
Dr. André Abts
Vice President Project Management CMC
ProtaGene, Germany
View trainer bio
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Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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CMC Analytical Comparability training organized by Fleming_Agenda Cover
CMC Analytical Comparability training organized by Fleming_Agenda Cover
CMC Analytical Comparability training organized by Fleming_Agenda Cover
key training

Topics

Analytical Comparability of Biologics (NBE & Biosimilars)

Case studies of analytical comparability studies pre- and post-approval

State-of-the-art protein analytics of CQAs

New developments in antibody structure and analytics

Case studies highlighting practical challenges and solutions

In vitro pharmacology

Benefits of attending

  • Understand
    • The regulatory requirements for characterization, comparability, similarity
    • Principles of protein structure and comparative analytics

  • Learn
    • How to define Protein Analytical Program & Critical Quality attributes
    • To design of an analytical strategy for comparability / similarity studies

  • Gain
    • Five steps to demonstrate comparability
    • New developments in Structure/ Function relationship
    • Protein Characterization according to ICH Q6B

Testimonials

Professional trainers, interesting presentations, helpful knowledge.
Edyta SmolińskaPolpharma Biologics
Very interesting course. The trainers are of a great value.
Sonia Ben AmorMOH
Really enjoyed the conference experience, content and organization. Overall it was a superb experience.
Stefanie Eggermont Associate Scientist, UCB, Belgium
I wish I had received this training earlier, it's very interesting, I'm glad I participated.
Daniela GantarProject Manager QC, Boehringer Ingelheim, Austria
The organization was excellent! It was an ideal forum for a CMC regulatory professional to learn more about analytical comparability methods and network with experts from pharma, biotech, CMOs, analytical service companies and regulatory authorities.
John Watkins PhDSenior Regulatory Affairs Manager, PPD, UK
All content was precisely determined, informative and helpful. Instructors were great also. Thank you very much, it was a pleasant and beneficial experience.
Duygu DaglikocaBiotech R&D Lab Executive, Ilko Pharma, Turkey
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Training tickets

Online Live Stream
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1496€
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Delegate Fee
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2196€
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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

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