Lyophilization has become an important development and commercialization strategy for modern parenteral products, including biologics, antibody-drug conjugates, mRNA-lipid nanoparticles, viral vectors, peptides, proteins and hydrolytically sensitive small-molecule injectables. For many of these modalities, limited aqueous stability can affect shelf life, distribution and commercial viability. This webinar explores a science- and risk-based lyophilization by design approach to developing robust, scalable and regulatory-ready freeze-drying processes.
Participants will gain a practical understanding of the three key stages of lyophilization: freezing, primary drying and secondary drying and how each stage influences product temperature, cake structure, residual moisture and long-term stability. The session will also examine critical thermal properties, including glass-transition and collapse temperatures, using techniques such as differential scanning calorimetry and freeze-drying microscopy.
The webinar will cover formulation–cycle co-development, lyoprotectant and bulking agent selection, heat- and mass-transfer considerations, design of experiments, ICH Q8(R2)-aligned design-space development and Process Analytical Technology (PAT). It will also examine monitoring approaches for establishing science-based drying endpoints and reduce unnecessary cycle time.
Common development and scale-up challenges, including cake collapse, inadequate drying, excessive residual moisture, vial-to-vial variability, poor process transferability and incomplete CMC justification, will be discussed alongside practical mitigation strategies. A representative case study will demonstrate how systematic cycle optimization reduced total cycle duration from 120 to 95 hours while maintaining critical quality attributes and improving potential manufacturing throughput.
The session will connect these development decisions with GMP scale-up, technology transfer and regulatory considerations, demonstrating how greater process understanding can support consistency throughout the product lifecycle.
Register for this webinar to learn how lyophilization by design can reduce cycle time, strengthen process robustness and support regulatory-ready scale-up.
Who Should Attend
This webinar will appeal to:
Formulation Development Scientists
Analytical Development / Analytical Sciences professionals
CMC Leaders and Technical Program Managers
Regulatory Affairs professionals
Quality and Compliance leaders
Technical Operations and MSAT teams
R&D Heads, Development Directors and Biologics/Peptide Program Leads
Decision-makers responsible for outsourcing strategy, CDMO partnerships and development acceleration
What You Will Learn
Attendees will learn to:
Apply
lyophilization by design
principles
Optimize formulation and freeze-drying cycles
Use
PAT and monitoring tools
to improve process control
Address common scale-up and transfer challenges
Reduce cycle time while maintaining product quality
Support regulatory readiness and commercial scale-up
Register free on Xtalks:
https://xtalks.com/webinars/lyophilization-by-design-improve-stability-and-accelerate-scale-up-broadcast-2/
