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  • Pharma
  • Training Courses | ClassroomTraining

Stability & Shelf Life of Biologics

  • 17 – 18 September 2025
  • Barcelona, Spain | 9:00 CEST - 17:30 CEST
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Stability & Shelf Life of 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
meet the training leaders
Jörg Engelbergs | Speaker | Fleming
Linkedin
Dr. Jörg Engelbergs
Paul Ehrlich Institute (PEI), Germany
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Robert Zoubek | Fleming
Linkedin
Dr. Robert E. Zoubek
Executive Consultant
Granzer Regulatory Consulting & Services, 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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Stability & Shelf Life of Biologics training organized by Fleming_Agenda Cover
Stability & Shelf Life of Biologics training organized by Fleming_Agenda Cover
Stability & Shelf Life of Biologics training organized by Fleming_Agenda Cover
key training

Topics

Guidance and regulation for stability of biologics with focus on biotech products

Advantages and limitations of accelerated and stress stability assessment

Biologics degradation by chemical, physical and microbiological factors

Biochemical and kinetic approaches to product stability

Analytical methodology for stability assessment

The role of excipients in stability of biologics

Transport and shipping impact on stability and shelf-life

Benefits of attending

  • Understand

    • How to apply accelerated and stress stability assessment to support your filing
    • How to improve the stability by picking the right excipient
    • Degradation of biologics by chemical, physical and microbiological factors
    • Bracketing and matrixing to cover your product stability

  • Learn

    • About guidance and regulatory expectations for product stability protocol
    • To identify proper analytical methods for stability assessment
    • What to consider for the correct packaging for biologics
    • About acceptation of reduced stability data for new formulations

  • Gain

    • A comprehensive overview on stability and shelf-life regulatory landscape
    • Harmonized ICH stability guidelines: Q1A-F and Q5C
    • Requirements for stability testing for biologics for clinical development and MAA
    • Contact with key leaders and regulatory authority to build up your network

Testimonials

This training was exactly what I needed. It covered all aspects of stability studies: what is needed, which method use, how to set a shelf-life, how to extrapolate... The regulatory part is very interesting. I learnt a lot and strongly recommend this masterclass!
Sandrine DerochetteProject Manager, Bioxodes
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Training tickets

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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

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