Lyophilization FAQs

What is lyophilization?

Lyophilization is also known as freeze drying. It is a dehydration process that takes place after a product has been frozen. Lyophilization is gaining popularity in the life sciences for reagents and assays due to its numerous benefits, including extended shelf-life and ease-of-use.

What kinds of lyophilization services do Argonaut offer?

Argonaut offers a wide range of reagent lyophilization services options. Our most popular format is LyoDose™ beads, although in situ, vials, and swabs are also common. Drug products are not able to be lyophilized at this time.

What are LyoDose™ beads?

Argonaut is the exclusive supplier of LyoDose beads, which are unit-dose lyophilized spheres. LyoDose beads offer significant advantages including faster reconstitution time, improved user experience, and reduced contamination risk.

Do you offer lyophilization services for my pharmaceutical product?

Unfortunately we do not offer pharmaceutical lyophilization services at this time. Please refer to our drug products manufacturing page for our full biopharma capabilities.

What types of products are typically lyophilized?

With a few exceptions, most liquid reagents can be lyophilized. Examples of projects include qPCR reagents, NGS kit components, and molecular diagnostics cartridges.

What is a lyophilization feasibility study?

Lyophilization requires careful optimization of parameters. Our lyophilization feasibility program determines the best manufacturing process for your product, prior to full-scale production. The feasibility study produces small batches of lyophilized product with three different excipients (inert components that stabilize products during the lyophilization process), which are then tested. This facilitates selection of the best excipient for optimal lyophilization.

Are your lyophilized products cGMP-compliant?

Yes, your product can be produced to cGMP compliance. Argonaut offers full cGMP manufacturing capabilities, and our lyophilization equipment is housed within our ISO manufacturing suites.

What are the benefits of lyophilization?

Lyophilization offers many advantages, including cost savings, improved user experience, and environmental responsibility.

Are lyophilization services expensive?

At production scale, units can be produced inexpensively in the same lyophilizer run. The initial investment in lyophilization services is quickly repaid with reduced cold chain expenses, fewer user errors, and longer expiration windows.

How quickly can I add lyophilization to my product line?

Turnaround times on lyophilization are usually quick, often 1-2 weeks. If you plan to manufacture under cGMP please allow time for documentation and technology transfer.

What cannot be lyophilized?

Lyophilization will not work with reagents containing glycerol and other cryoprotectants.

I tried lyophilization before and it didn’t work. Why should I try it again?

Lyophilization is a complex process that requires extensive optimization. Argonaut has decades of experience in setting these parameters and selecting excipients. As a result, our lyophilization feasibility program has a high success rate in achieving a suitable product.

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