Yes. These are available in custom fill/package.
We can provide your manufacturing team with controls.
Yes- this is part of our core business.
Argonaut offers formulation, vial filling, finishing, and analytical support for the biopharmaceutical industry. Please see below for compatible vials.
Our team comes from backgrounds at leading drug product manufacturers including Aji Bio-Pharma (Althea), ThermoFisher, Allergan, and more. Our COO Chris Duffy and VP of Regulatory & Quality Stacy Sutton are well known in the industry.
Argonaut operates a custom-designed, state-of-the-art Bausch + Ströbel VarioSys line with SKAN isolator technology. Our line utilizes B+S’s ADVANCEDfill technology to maximize yield, and our isolator-based filling eliminates the need for personnel intervention.
Argonaut offers full service analytical support, please see our QC page for a more comprehensive description:
Yes, our line uses SKAN isolators.
Argonaut plans to add commercial support in the future, and our equipment and facility are commercial-ready. If you are interested in working with us to progress from clinical to commercial, please contact us to learn more.
Yes, Argonaut offers validated storage at ambient, +4C, -20C, and -80C.
At this time we do not work with high-potent drugs of any type.
Our VarioSys line has a modular design that enables addition of syringe or vial filling capabilities. Please contact us to learn more.
We use ready-to-use, pre-sterilized nested ISO vials. Currently vials from 2R through 30R are available.
At this time we do not offer drug synthesis. However, we are able to formulate using your supplied API.
While Argonaut is a leading supplier of lyophilization services for the life sciences industry, at this time we do not offer aseptic lyophilization. We plan to add these capabilities in the future, please contact us to learn more.
Organizations of all sizes can benefit from contract manufacturing. Large or small, working with a CMO can reduce operating costs, free up in-house resources, and accelerate time-to-market. A contract manufacturer provides your company with decades of expert experience and up-to-date regulatory compliance.
Please contact us and we can discuss the right solution for your business.
Contract manufacturing can be completely turnkey, or as minimal as you like! Argonaut offers many services, and you select those that make sense. The overall process is similar for most projects: kickoff, tech transfer & documentation, production, and delivery.
Argonaut is a services-only company that is completely dedicated to contract manufacturing. While many competitors are OEMs that offer contract work as a side business, Argonaut will never compete with you in the market or prioritize our own work over yours. Your intellectual property is safe with us, and we aim to function as if we are your own manufacturing operation. Argonaut offers comprehensive capabilities from sourcing to shipping, and decades of experience for every step of the way.
- Cost: Often a major factor, as contract manufacturing transforms fixed costs into variable costs and reduces overhead.
- Speed: A CMO can leverage its established supply chain to support your project, and most required equipment and personnel are already in place.
- Expertise: CMOs bring a depth of knowledge in specific areas of production such as lyophilization, technology transfer, and shipping.
For more in-depth content here are our white papers.
Argonaut has successfully worked with clients across the United States and internationally. Carlsbad may be our home, but our reach is global. We welcome clients located anywhere.
Carlsbad, California is one of the leading centers of biotechnology excellence and has a talented workforce. Argonaut was established here to be at the epicenter of innovation.
Argonaut chooses to work with trusted specialists for those services outside of our scope. If your project requires something we do not cover, we will either refer you to one of our ecosystem partners directly or contract them on your behalf. We frequently work with these partners and can offer you a seamless experience.
The best time is now. Argonaut frequently works with very early-stage clients, and even offers a program designed to maximize flexibility. Speaking with our manufacturing experts before your product is finalized is the best way to avoid costly mistakes that could delay production.
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Argonaut’s Quality Management System is compliant to ISO 13485:2016, cGMP, and quality system regulations (21 CFR 820).
We provide quality oversight in all processes from receipt to release. We take each client’s needs into account and work closely with you to customize a quality plan that works for you, regardless of size or complexity of project.
The US Food and Drug Administration (FDA) has been exercising enforcement discretion for laboratory developed tests (LDTs) and is now proposing to regulate these products. LDTs are likely to require cGMP in the near future, so manufacturing your product to these standards now protects you. Manufacturing under cGMP regulations can be a confusing, costly, and time-consuming process. Additionally, regulations are constantly evolving and can be difficult to keep up with on your own. By choosing Argonaut, you can be assured that your products will meet compliance requirements.
Argonaut offers a la carte quality control testing as one of our services.
Tech transfer enables Argonaut to build your products in our facility. This process takes your existing documentation and converts it into formatted, ready-to-use work instructions and spec sheets that are necessary for cGMP manufacturing. In order to be cGMP-compliant these documents must be entered in our eQMS, which is why your existing files need to be converted. You will own these documents and can access them on demand.
Your intellectual property is of the highest priority to us. We safeguard this with state-of-the-art information technology and strictly controlled access. Our systems are cloud-vaulted, meaning there is no onsite server to protect. All protocols and methods are securely stored in our electronic quality management system (eQMS).
The first step towards a quote is speaking with our team. Our experts will discuss your project with you and help evaluate which services you need. We accept most common RFP package formats, but if you do not have one we can work with you. At a minimum you will need a bill of materials, instructions for production, and quantity desired.
Argonaut is strictly a services company. We will never sell our own products or compete in the market with clients.
Upon contract, Argonaut provides you with a client services manager. The manager gives you increased visibility into your project, essentially operating as your eyes and ears at our facility. Your client services manager is your primary point of contact, and will schedule frequent progress meetings to keep you updated.
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 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.
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 do not offer pharmaceutical lyophilization services 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 services 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.