Encore Webinar Hosted by Xtalks -- Lyophilization by Design: Improve Stability and Accelerate Scale-Up

In this free encore webinar, explore practical approaches to developing robust and scalable freeze-drying processes. The featured speaker will examine how formulation design, thermal characterization, cycle optimization and process monitoring can help address lyophilization challenges, improve product stability and support efficient scale-up and regulatory readiness.

TORONTO, Nov. 9, 2026 /PRNewswire/ -- Challenges such as cake collapse, inadequate drying, excessive residual moisture and vial-to-vial variability can make lyophilization development and scale-up difficult. This webinar will explore how a science- and risk-based lyophilization by design approach can help develop robust, scalable and regulatory-ready freeze-drying processes.

Lyophilization plays an important role in developing and commercializing 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 products, limited aqueous stability can affect shelf life, distribution and commercial viability.

The featured speaker will walk attendees through the three key stages of lyophilization—freezing, primary drying and secondary drying—and explain how each stage affects product temperature, cake structure, residual moisture and long-term stability. The session will also cover critical thermal properties, including glass-transition and collapse temperatures and 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).

Attendees will also learn about monitoring approaches to establish science-based drying endpoints and reduce unnecessary cycle time.

The speaker will share a case study demonstrating how systematic cycle optimization reduced total cycle duration from 120 to 95 hours while maintaining critical quality attributes and improving potential manufacturing throughput.

The webinar will also look at poor process transferability and incomplete CMC justification, along with mitigation strategies. The discussion will connect these development decisions to GMP scale-up, technology transfer and regulatory considerations, showing how stronger process understanding can support consistency throughout the product lifecycle.

Register for this webinar to explore how lyophilization by design can help shorten freeze-drying cycles, maintain product quality and support scale-up and regulatory readiness.

Join M.S. Vijaykanth, PhD, SVP & Head – R&D, OneSource Specialty Pharma, for the live webinar on Thursday, November 26, 2026, at 8am EST (2pm CET / EU-Central).

For more information, or to register for this event, visit Lyophilization by Design: Improve Stability and Accelerate Scale-Up.

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Soumya Shashikumar
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