Lyophilization of Reagents- Go Ambient!
Developing a lyophilization process for your reagents can be challenging. Critical drying parameters must be mapped, excipients tested, and functionality determined. Knowledgeable personnel are hard to acquire. And then you have to scale everything up.
The Argonaut team now includes the pioneers behind LyoDose™ beads, bringing decades of lyophilization experience to our broader manufacturing portfolio. The result? A practical, no-nonsense approach to lyophilization projects. We know what works, and your project reaps the benefits.
The Ambient Advantage
Transitioning from liquid solutions to LyoDose beads or lyophilized powders can generate significant technical advantages. However, the operational benefits could be even greater and may encompass:
- Lowering cold chain costs
- Cutting waste by reducing carbon footprint (Green Initiatives)
- Fewer user errors by reducing mixing steps and service calls
- Preventing obsolete inventory by extending shelf-life
LyoDose Beads
LyoDose beads are spheres of customizable lyophilized material that contain a specified volume of material per reaction, while maximizing surface area for rapid reconstitution.
- Room-temperature storage
- Unit dose 2µl-60µl volume
- Up to 20 year stability
- Customizable formulations- from latex solutions to paramagnetics and more
Read more about the advantages of lyophilized beads here.
Vials & Powders
Sometimes conventional powders are preferred for your application, and Argonaut delivers these with the same room temperature storage and stability as LyoDose beads.
- Microbeads or bulk powders
- Vials
Argonaut Infrastructure
Manufacturing experts see beyond the walls and software package to evaluate key capabilities. Our infrastructure complements your need for quick product deployment, including:
- Humidity-controlled environments
- ISO particulate control
- Lyophilizer & specialized equipment
- Statistical Process Control
- FDA cGMP compliance
- Custom packaging
- Scale: Currently 500K+ LyoDose beads per week, now scaling to 1M+ per week
FAQs
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.
Argonaut offers a wide range of reagent lyophilization options. Our most popular format is LyoDose™ beads, although in situ, vials, and swabs are also common.
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.
Unfortunately we cannot perform pharmaceutical lyophilization at this time. Please refer to our drug products manufacturing page for our full biopharma capabilities.
With a few exceptions, most liquid reagents can be lyophilized. Examples of projects include qPCR reagents, NGS kit components, and molecular diagnostics cartridges.
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.
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.
Lyophilization offers many advantages, including cost savings, improved user experience, and environmental responsibility.
At production scale, units can be produced inexpensively in the same lyophilizer run. The initial investment in lyophilization is quickly repaid with reduced cold chain expenses, fewer user errors, and longer expiration windows.
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.
Lyophilization will not work with reagents containing glycerol and other cryoprotectants.
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.