Lyophilization by Design:
Improve Stability and Accelerate Scale-Up (Broadcast 1)
About this webinar
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.
Can’t attend on this date?
Click here to register for a second broadcast of this webinar.Broadcast 2: Thursday, November 26, 2026 | 8am EST / 1pm GMT / 2pm CET
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
Featured Speakers
M.S. Vijaykanth, PhD
Vijaykanth is the SVP and Head of Research & Development at OneSource, bringing over 21 years of extensive experience in sterile pharmaceutical research and development. His expertise encompasses complex injectables, novel drug delivery systems and specialty generics for regulated markets worldwide.
He leads the organization’s R&D development strategy, driving innovation in sterile product development, process optimization and regulatory-aligned formulation design. Vijaykanth has played a pivotal role in establishing robust development frameworks and building scalable R&D capabilities that enable the successful execution of niche and technically challenging sterile programs.
Prior to joining OneSource, he held senior leadership positions at leading pharmaceutical organizations including Intas Pharmaceuticals, Astron Research and Mylan, where he served as Director – R&D. Over the course of his career, he has successfully led cross-functional teams and advanced multiple complex development programs across global markets.
Vijaykanth holds a PhD in Pharmaceutical Sciences from DAVV, Indore and a Master’s degree from Dr. H.S. Gour University, Sagar. He has authored numerous scientific publications and holds several patents in the field of pharmaceutical development.
Partner for this event
OneSource
OneSource Specialty Pharma Limited is a pure-play specialty pharmaceutical CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five state-of-the-art manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,600 professionals. OneSource with its development capabilities, industry leading manufacturing capacities, and strong compliance track record, has won trust of global pharmaceutical companies seeking efficient, end-to-end solutions. For more information, please visit www.onesourcecdmo.com