meet the training leaders
Dr. Robert E. Zoubek
Executive Consultant
Granzer Regulatory Consulting & Services, Germany
Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!
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
Understand
Learn
Gain
The course looks at how accelerated and stress stability assessment can support filings, long-term stability prediction and shelf-life extrapolation. It is designed to help teams connect stability strategy with practical regulatory expectations from clinical development through Marketing Authorization Application.
The agenda covers chemical, physical and microbiological degradation factors, including hydrolysis, deamidation, oxidation, aggregation, particulate formation, subunit dissociation, denaturation and unfolding. The emphasis is on recognising stability challenges and applying this understanding to real product discussions.
Participants review analytical methodology for stability assessment, including how to select the right methods for a product, approach in-use stability testing, distinguish release and stability specifications, and consider upcoming analytical technologies.
The course covers the role of excipients in biologics stability, including excipient-induced stability improvement, compatibility studies, excipient categories, parenteral biologics formulations, lyo versus liquid approaches and formulation case studies.
The agenda addresses packaging, transport and shipping impact on stability and shelf life, including container closure risks, GDP guidelines, temperature excursion management, general transport testing methods, ISTA guidance and PDA technical report considerations.
Participants learn how bracketing approaches and reduced stability designs fit into the broader stability strategy. The course connects these topics with regulatory expectations, protocol planning and the practical challenge of covering product stability efficiently.
The programme examines the European regulatory framework, EMA stability guidelines for biologics, ICH Q5C and supportive ICH guidance, stability requirements from First-in-Human studies to Phase III and Marketing Authorization Application, and shelf-life justification for regulatory submissions.
The course is relevant for product stability specialists, QA/QC teams, regulatory managers, CMC leaders, formulation scientists, R&D professionals, lead analysts, lab technicians and consultants working with biologics stability, analytical strategy, formulation development or regulatory submissions.
