Lyophilization Development: Quality by Design Approach
Lyophilization, or freeze-drying, addresses stability challenges associated with complex APIs, biologics, microbiomes, gene therapies, viral vectors, liposomes, and nanoparticles. This process is particularly advantageous for parenteral drug developers, as it converts unstable liquids into stable powders suitable for injection, enhancing packaging and transfer as a finished drug product. Additionally, lyophilization is employed to produce stable intermediates in drug development, particularly for hydrolytically unstable components like PLGA microparticles or fragile APIs, extending their shelf life. For instance, APIs undergoing high-energy media milling may be lyophilized before incorporation into oral solid dosage forms. While lyophilization offers substantial benefits and commercial viability, it also introduces complex formulation processes and manufacturing challenges. Each product, especially those involving nanoparticles, microparticles, liposomes, or microbiomes, requires customization and extensive lyophilization cycle development. This e-book explores these challenges and proposes mitigation strategies through a Quality by Design (QbD) approach.
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