Biotechnology drugs are very effective but complex compounds. Often, this means they are sensitive to environmental influences and can be quite unstable, affecting shelf life. For many developers and manufacturers, lyophilization, combined with the packaging flexibility it offers, is often the answer to this problem.
The increasing popularity of biotechnologically manufactured drugs has created a challenge for companies because of their high level of instability and reduced shelf life. Most often, lyophilization is the answer to this problem. And, because it also offers a wide-range of packaging solutions such as simple vials, to sterile-water-for-injection syringes for reconstitution to special dual-chamber syringe and cartridges, it can also provide a competitive edge against competition. However, developers and manufacturers must consider this process early on if they are to be successful in their program.
This article discusses the lyophilization process, and the packaging flexibility and the competitive edge it offers. It also reviews how a long-term partnership with an experienced Contract Development and Manufacturing Organization (CDMO) can provide efficient solutions to the set of challenges revolving around lyophilized substances.