Can you describe the process of lyophilization?
Lyophilization, also known as freeze dying, is the process by which water is removed from a product by applying a vacuum during freezing. This process is widely used in the food industry (in the production of instant coffee, dried fruits and herbs for example) but is becoming increasingly common in research and diagnostics (to generate PCR and enzymatic reagents), and pharmaceutical production (in drug formulation and vaccine storage).
Lyophilization begins with primary drying when the initial freezing of the product is performed under reduced pressure. Water directly transitions from solid phase to vapor phase, bypassing the liquid state. Ultimately, 95 percent of the moisture is removed from the product. During the secondary drying stage, the temperature is decreased again and kept under a high vacuum, resulting in a completely dehydrated product.
What are the benefits of lyophilization compared to other stabilization methods?
Lyophilization ensures retention of the functional characteristics of the original biological material, whilst rendering them biologically stable. Other preservation methods cause damage to the product in the form of ice crystals, which can break down DNA and enzymes, negating the functional properties of products like diagnostic assays. Air-dried products dehydrated with heat, fans, or dehydration chambers, have a shorter shelf life and may suffer residual damage from the drying process. In laboratory kits, damage to primers or glycerol is detrimental to downstream experiments. These problems can be avoided by using lyophilization.
How do you offer lyophilization using a scalable model?
Lyophilization is an extremely involved process, and that’s where a contract laboratory like Biofortuna can help. We work in partnership with our clients, offering insight and advice right at the start of the development process. Rather than customers having to reinvent the wheel and learn lessons through trial and error, we can put them on the road to success far earlier. When we take on a project, we can help analyze the feasibility, development, and future manufacturing pipeline for the product, based on our past knowledge, thus ensuring a much smoother transition from development to full scale commercial manufacture.
What are the challenges of lyophilization?
Every assay formulation is different, so a tailored approach is needed for each situation. Biofortuna has an experienced team and a state-of-the-art facility for performing lyophilization. When you add up the years of experience on our team, we represent over half a century of learning and troubleshooting. From advising on optimization steps to detailed knowledge of ideal freeze-drying conditions, we can prevent mistakes in selection and development of lyophilization procedures, increasing the probability of success and speed to result.
How does working with a contract manufacturer impact intellectual property (IP)?
Everyone likes transparency. When working with us, developers retain their intellectual property, and don’t need to tell us what’s in the formulation they’re providing. We advise them on how to expedite the process and get their product to market faster without the high upfront costs and associated overhead of lyophilization. We are ISO 13845 certified and are FDA-registered. This enables our clients to bring ideas and products to market more quickly, without sacrificing intellectual property or quality.