OSD
Lyophilisation: Key to overcoming stability hurdles for complex therapeutics
The rise of advanced therapies, from nucleic acid-based medicines and viral vectors to lipid nanoparticles (LNPs) and mRNA, is transforming modern healthcare. However, these complex modalities present new challenges for formulation, stability and distribution. Their fragility under environmental stress, combined with reliance on energy-intensive cold chain logistics, makes ensuring safe and reliable global access increasingly difficult.
Lyophilisation is emerging as a critical stabilisation strategy, offering extended shelf life, improved product integrity and reduced dependence on ultra-cold storage. Already established in protein and antibody formulations, its role is expanding to meet the needs of next-generation medicines.
- Optimisation at every stage
Delivering the full benefits of lyophilisation depends on addressing a series of interconnected challenges, from early formulation design through to large-scale commercial manufacturing. - Formulation design
Careful selection and balance of excipients is vital to protect molecules during freezing and drying. For nanoparticles and nucleic acid-based products, incompatibilities can compromise stability and biological activity. - Process development and control
Freezing, primary and secondary drying must be finely tuned to prevent collapse, maintain consistency and safeguard efficacy, while also ensuring efficiency at scale. - Scale-up and manufacturing
Moving from laboratory to commercial production demands rigorous process validation, robust GMP controls and batch-to-batch uniformity, all under regulatory scrutiny. - Sustainability considerations
By reducing cold chain dependence, lyophilisation supports accessibility and environmental goals, though further innovation in energy efficiency will be essential.
Choosing the right strategy requires navigating all these dimensions in parallel. For developers, engaging expertise early is key to ensuring complex therapeutics can be delivered safely, reliably and at commercial scale.
Enabling tomorrow’s therapies
Ensuring the stability of complex medicines will increasingly hinge on the evolution of lyophilisation itself. Beyond formulation, process optimisation, scale-up and sustainability, progress will rely on advances in analytical tools, innovative drying technologies and strategies that guarantee rapid and reliable reconstitution. Regulatory requirements and supply chain resilience add further layers of challenge, but continued innovation in lyophilisation is already opening the door to new solutions.
To learn more about this topic and the approaches Recipharm uses to overcome lyophilisation challenges, read the full article below.
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