Your Solutions, Our Team

We can support your team at any product stage, from launch through revitalization. Click the stage/technology that interests you.

Product Launch
Scale-Up & Volume
Decline/Sunset
Lyophilization

Product Launch

Transitioning out of research and into the market is tricky. The art inherent in the science becomes the art of manufacturing. Flexibility needs to be retained, from BOMs to protocols. What was done individually by hand is now done by teams and machines. New opportunities rise. Can you capture the cost savings? Argonaut’s team has extensive experience in this key phase, having launched hundreds of products in the industry. Our team can help your team:

  1. Protocol Design
  2. BOM construction and sourcing
  3. Scaling & Ramp-to-Revenue
Call and let’s get your product to market!

Scale-Up & Volume

Putting together that logical flow to gain efficiencies is no easy task. When your team is faced with high mix and low volume products it is particularly onerous – time to market is as critical as quality and cost. Yet balancing capacity is near impossible as each product has unequal work times. Orders flowing onto the work floor create chaos and bottle-necks, a constant game of whack-a- mole. Argonaut’s experience within biotech and across industries can help your team:

  1. Lean Manufacturing Design & Implementation
  2. Specialized kitting and product planning
  3. Process optimization and value engineering
Call and let’s make your operation run smoother.

Decline/Sunset

Just because a product has been in the market for a while doesn’t make manufacturing decisions any easier. Key customers still need it, but inefficiencies are cropping-up: Smaller batches, less frequent cycles, and potential loss of manufacturing knowledge. Is it time to free up your resources, or is it time to revitalize the product? With either decision, our team can help your team:

  1. Protocol Transition
  2. Knowledge Transfer & Documentation
  3. Small Lot Manufacturing
Call and let’s help make the product transition

Lyophilization

Cut cold chain costs, stabilize reagents, extend shelf-life, and improve user experience by choosing to lyophilize your formulations. The LyoGen team has joined Argonaut and brings the experience, customized tooling, and protocols to get your project into a new format that re-constitutes instantly. Options include:

  1. LyoDose™ beads for unit dosage
  2. Microbeads or bulk powders in vials
  3. Custom formulation stabilization
  4. Custom packaging
  5. FDA cGMP compliance
Call and Get Your Product in the Optimal Format

FAQs

Argonaut is a contract manufacturer serving the molecular diagnostic, life science, and pharmaceutical industries. Our capabilities include:

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.

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.

There are many ways to keep up-to-date with our latest news and content. Argonaut offers an email newsletter, and we are active on LinkedIn, Twitter, and Facebook. Be sure to follow us!

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.

DPM is taking bookings in Q2 of 2019. Argonaut’s custom DPM line will maximize product yield, reduce risk, and comply with all FDA and EU regulatory requirements.

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