Drug Product Stability: Long Term and Accelerated Stability is Just the Beginning

WEBINAR

In this webinar, you will learn:

• Guidance on Advanced Therapy Medicinal Products (ATMPs)/Cell and Gene Therapies (CGT)
• Short term and in-use storage condition requirements for drug products
• What development stages need stability data

Stability studies guide the understanding of how long and under what conditions drug substances and drug product are safe and efficacious. Long term and accelerated studies provide essential information but studies such as in-use, photostability and temperature excursion studies provide pragmatic data to guide the use of products in real world scenarios and quality control activities. These auxiliary studies require careful planning and are discussed as they apply to Advance Therapy Medicinal Products/GCT and traditional biological drug products. Recent draft guidance from both the USP and ICH have highlighted the need for these studies in successful regulatory submissions.