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Stability Testing of Biological Drug Products
Pharma & Biotech

Stability Testing of Biological Drug Products

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Understand the challenges of different biological products

Understand the challenges of different biological products

Learning Objective

Learn how APIs, formulations and storage conditions affect stability

Learn how APIs, formulations and storage conditions affect stability

Learning Objective

Apply analytical methodologies for stability assessment

Apply analytical methodologies for stability assessment

Learning Objective

Identify appropriate packaging and transportation

Identify appropriate packaging and transportation

Learning Objective

How to accelerate stability studies

How to accelerate stability studies



KEY TOPICS

Regulatory guidance on stability of biologics (EMA & FDA)
Stress testing of biologics
Packaging, storage and logistics
Analytical methods, statistical analysis and stability data
Product recalls
Quality by design (QbD) principles for product stability
ICH Q1 A-F