Lyophilization Services

Proteins and antibodies are highly sensitive molecules that can easily denature, aggregate, or chemically degrade. Lyophilization (freeze-drying) is an effective method to preserve their stability by removing water through sublimation under vacuum. This process produces a dry powder without exposing the product to damaging high temperatures and significantly reduces chemical degradation, resulting in improved shelf life.

At Biocult, lyophilization is routinely used to maintain the biological activity of antibodies and proteins.

The Importance of Formulation

Successful lyophilization depends strongly on formulation. Without the right excipients, proteins and antibodies may become unstable during drying or storage.

• Sugars such as trehalose or sucrose act as lyoprotectants, stabilizing protein structure by replacing water molecules.
• Amorphous matrices with a high glass transition temperature (Tg) are preferred, as they prevent harmful crystallization.
• Non-ionic surfactants (e.g. polysorbate 20 or 80) help reduce surface-induced aggregation.
• Carefully selected buffers maintain pH stability during freezing and drying, avoiding pH shifts caused by buffer crystallization.

Common Challenges in Lyophilization

• Product collapse: Excess heat during primary drying can cause structural collapse, negatively affecting reconstitution and product quality.
• Inadequate formulation: Poor stabilization can lead to aggregation or loss of activity.
• Inefficient drying: Slow or inconsistent sublimation may result in long cycles or incomplete drying.
• Storage conditions: Even lyophilized products require proper storage to prevent degradation caused by moisture, oxygen, or light.

With the right expertise, formulation, and process control, lyophilization is a powerful tool to ensure long-term stability and performance of protein-based products.

Stable Antibodies, Reliable Results

At Biocult, controlled lyophilization preserves the stability and biological activity of proteins and antibodies, ensuring reliable, long-term performance.

Curious what we can do for you? Contact us and let’s create greatness together!