Lyophilized APIs

Expertise in Lyophilization of Sterile Powders

At nanoCaps, we bring extensive expertise to the lyophilization of sterile drugs, covering everything from formulation and cycle development to full-scale manufacturing for both clinical trials and commercial production. Our advanced freeze-drying processes are crucial in developing complex parenteral products, optimizing efficiency to reduce costs and enhance productivity.

Our skilled professionals provide support in developing sterile powders designed to improve drug stability and extend shelf life, whether for clinical or commercial use. We specialize in working with complex modalities such as peptides, oligonucleotides, antibodies (including monoclonal), proteins, and traditional small molecules, strengthening your sterile powder supply chain.

What is a Lyophilized Drug?

A lyophilized drug is a medication that has undergone a specialized low-temperature dehydration process known as lyophilization. This process involves freezing the product, reducing pressure, and removing ice through sublimation. Unlike traditional dehydration methods that rely on heat, lyophilization preserves the integrity and efficacy of the drug, making it suitable for long-term storage.

The function of a Lyophilized Drug

Lyophilization removes moisture from a drug, converting it into a stable, dry powder that is sealed in a glass vial. This method ensures the drug is easy to store, transport, and later reconstitute for injection. Before administration, the lyophilized drug must be reconstituted by mixing it with bacteriostatic water for injection—a sterile water solution containing a small amount of benzyl alcohol to inhibit bacterial growth. This process is essential for ensuring the stability and effectiveness of injectable drugs until they are ready to be used.