Summary
The Stability Testing for Biologics Masterclass is a comprehensive two-day webinar designed to equip professionals with the knowledge and tools to manage the stability of biologic products effectively. Participants will gain a deep understanding of regulatory guidelines, critical quality attributes, and the parameters that influence the stability of biologics in various formats, including liquid, frozen, and lyophilized forms.
The course will explore advanced analytical methods, stress testing, and the design of stability study protocols, providing actionable insights into optimizing stability throughout the product lifecycle. Attendees will delve into real-world case histories of key biologics such as Insulin or COVID-19 vaccines, learning from past challenges and product recalls to implement best practices for future success.
Additionally, the course addresses practical considerations such as storage conditions, expiration dates, and managing stability during transportation. Participants will also have the opportunity to engage in hands-on workshops, interactive discussions, and a dedicated Q&A session with experts to address their specific challenges.
This masterclass is essential for professionals involved in biologics development, manufacturing, and quality assurance who seek to enhance their expertise and stay ahead in the dynamic field of biologics stability.
Learning Objectives
- Gain a clear understanding of the critical factors influencing biologics stability.
- Learn how to effectively align stability practices with global regulatory expectations.
- Develop skills to design and optimize stability protocols for both short-term and long-term studies.
- Explore practical strategies for maintaining biologics stability during storage and transport.
- Understand how to identify and manage stability risks across different product formats.
- Acquire tools to interpret and apply stability data for decision-making and compliance.
- Draw actionable insights from real-world case studies and product recalls.
- Stay ahead with knowledge of innovative trends and advancements in stability testing.
- Enhance your ability to troubleshoot stability challenges and implement preventive measures.
- Leave the course with practical solutions and expert insights tailored to your biologics stability needs.
Key Topics
- Regulatory guidelines and global standards for biologics stability testing
- Identification and management of critical quality attributes for biologics
- Parameters and intervals for stability testing across different formats (liquid, frozen, lyophilized)
- Advanced analytical methods for evaluating biologics stability
- Stress testing protocols and their role in product development
- Design and implementation of long-term and accelerated stability studies
- Setting optimal storage conditions and determining accurate expiration dates
- Managing stability challenges during transportation and mitigating risks
- Case studies of stability experiences with Insulin or COVID-19 vaccines, and more
- Future trends and innovations in biologics stability testing
Who should attend?
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Stability Testing for Biologics
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
