As biologics such as vaccines, gene therapy and therapeutic proteins continue to advance to commercial viability, their complexities when compared to small molecules will necessitate new and novel approaches. These drugs are susceptible to conformational changes, protein aggregation, and other issues resulting from temperature changes, freeze-thaw cycles, the introduction of certain excipients and buffers, and various other factors.

Lyophilization offers some alluring advantages in today’s complex and challenging market: by removing the moisture from the product, developers can extend its stability for more than two years, which can prove crucial in paradigms like the current COVID-19 pandemic.