The process of lyophilization is complicated and requires a lot of time and investment. This creates challenges in the process of scaling up and technology transfer. Most pharmaceutical companies have relied on trial and error to optimize the process. While this is a necessary cost in biologic drug manufacturing, it disrupts pipeline progression and can prevent more efficient manufacturing. That's why choosing a specialized CDMO is essential. There are many advantages to working with a specialized CDMO.
Another benefit of lyophilization is the ability to reconstitute pharmaceutical products. Using a diluent, such as sterile water, is crucial to administering the drug. Usually, a reconstitution kit contains the diluent and medication vials. The injection needle is also included in the kit. For instance, in March 2022, Akston Biosciences Corporation, a lyophilized drugs and liquid vials provider in the U.S., partnered with Biolexis to accelerate licensing, production, and commercialization of Akston’s AKS-452, a potential COVID-19 vaccine candidate.
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