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Lyophilization in the Pharmaceutical and Biotechnology Industries
For more than 50 years, lyophilization — or freeze-drying — has been an effective method used in laboratory and commercial production for stabilizing and preserving valuable, heat-sensitive products. Products commonly preserved by lyophilization include: pharmaceutical and biotechnology drug formulations, nutraceuticals, cosmeceuticals, biomaterials, blood plasma, bacteria and other microorganisms. Lyophilization and freeze-drying are synonymous terms and can be used interchangeably.
The key concept of lyophilization is sublimation – a process where a substance changes from a solid to a vapor without passing through a liquid phase. When comparing freeze-dried products with their liquid counterparts, they have:
- Longer shelf life
- Less cumbersome storage, handling and distribution requirements
- Lower shipping costs because of reduced weight, especially for bulk applications
- Reduced need for cold storage environments
Stabilize liquid drug formulations and/or parenterals through lyophilization
The process of freeze-drying is used often to stabilize delicate and heat-sensitive materials and compounds such as:
- proteins
- peptides
- biologics
- vaccines
- enzymes
- microorganisms
- monoclonal antibodies
- parenterals
- pharmaceuticals
- blood fractions
- oglionucleotides
- blood plasma
- diagnostics
- nutraceuticals
- cosmeceuticals
- biomaterials
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GORE™ LYOGUARD® Freeze-Drying Products have modernized the way in which the pharmaceutical and biotechnology industries process drugs providing unique solutions to the sterility and processing challenges of lyophilization.