Tailored, Cutting-Edge Lyophilization For Biologic Stability

Dr. Brecht Vanbillemont, Senior Scientist, and Dr. Lisa Besslich, Rer. Nat., Client Project Manager

As biologic therapies become more complex, maintaining long‑term stability is increasingly difficult. Modern lyophilization—an established freeze‑drying technique—offers an effective way to protect sensitive biologic drug products. Many biologics are too unstable to store as liquids and instead require frozen conditions, which add major logistical and cost challenges across global supply chains. By converting these delicate molecules into solid, stable powders, lyophilization allows storage at room or refrigerated temperatures, greatly reducing cold‑chain dependence and improving global accessibility.

Demand for lyophilization continues to grow as biologic pipelines diversify. Complex modalities such as antibody–drug conjugates often require freeze‑dried forms because their components break down too quickly in liquid formulations. Choosing between a liquid or lyophilized format depends on factors such as molecular stability, patient needs, delivery method, and commercialization goals.

Precision‑driven process development is essential for successful lyophilization. Advanced modeling, quality‑by‑design approaches, and modern freeze‑drying technologies help teams optimize stability, scale manufacturing efficiently, and ensure product robustness. With these tools, lyophilization remains a key enabler of safe, reliable, and widely accessible biologic therapies.