Pharma & Biotech

Stability Testing for Biologics

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

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

TRAINER

Dr. Felix Tobias Kern

Associate Director – Head of Compliance Launch and Technology Center

Dr. Felix Tobias Kern is the Associate Director – Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology. In the past 6 years he worked as a QA Manager in a worldwide operating medical device and medicinal product company, as well as head of manufacturing for the production of bulk tablets. Same time he gave lectures and practiced as consultant in the fields of GMP, quality, risk management, as well as regulatory requirements in the fields of medicinal products and medical devices. On top, Felix was involved in mRNA projects in Europe concerning design, manufacturing and quality topics of mRNA processes. We are live on webchat!

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Video Invitation

Watch the video invitation from the trainer.