Enabling Innovators, Creators & Leaders

We provide manufacturing solutions for diagnostics & life science applications across a variety of needs, from Research Use Only to turn-key regulated diagnostics. With cGMP, FDA registration, and ISO 13485:2016 certification, we build quality into each step, every time.

RUO
Research Use Only
POC
Point of Care
IVD
In Vitro Diagnostics

Your Solutions, Our Team

Manufacturing isn’t easy – especially in Diagnostics & Life Sciences. That’s why our expert team is here to focus on manufacturing your product. From New Product Introduction to Long Tail product portfolios nearing the end of their life cycle, our team has the expertise to efficiently manufacture the high quality products you require.

Argonaut offers a complete suite of services from supply chain management, technical transfer, engineering development and first article builds, to cGMP manufacturing,  and quality and regulatory services. Argonaut is here to support your operations in new product introductions, scaleup, ongoing manufacturing or surge support.

cGMP

Scalability & Flexibility

We are the fastest growing cGMP manufacturer in the Diagnostics & Life Sciences manufacturing space. Our adaptability and flexibility, combined with the leadership and experience of our team in world class facilities, enable us to effectively meet your needs.  The COVID Pandemic of 2020 clearly demonstrates both the urgency and the advantage of cGMP manufacturing that is scalable, resilient, and nimble.

Experience and Training

We have decades of combined manufacturing experience from RUO to IVD cGMP products. Argonaut utilizes continuous improvement processes (CIP) to advance our manufacturing technologies, and the training of our team. Importantly, we partner with you to share our experiences and enable your success.

We Support your Team at any Product Stage

Product Configuration

From incremental to break-through products, Argonaut and its ecosystem partners have extensive experience in this key stage, having launched hundreds of products in the industry.

Process Development

From developing to optimizing processes, Argonaut improves your biotech manufacturing quality and reliability.

Technology Transfer

Bridging skills, technologies and manufacturing methods between facilities can be difficult to execute. Leveraging the Argonaut team with yours makes transitions easier than ever.

cGMP Manufacturing

Balancing capacity with demand forecasts requires planning and operational flexibility. Argonaut handles your cGMP manufacturing requirements - from the routine to the complex.

Quality Control

Quality is the key to biotech manufacturing and Argonaut can assist your efforts, from preclinical through commercialization.

Quality Assurance

Preventing defects from entering your product build gives you confidence the standards you establish are being met. Argonaut can help qualify systems and suppliers and train staff on risk mitigation.

Shipping & Storage

Want to keep your on-site facilities maximized toward research and development? Free up high-value space using dedicated Argonaut warehousing for storing raw materials and finished goods.

Supply Chain

Our solution is customizable, scalable, and regulatory integratable with full solutions – supply chain, formulation, lyophilization, and fill finish.

Product Launch
Transitioning out of research and into the market is tricky. The art inherent in the science becomes the art of biotech 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.
Technical Transfer
Bridging skills, technologies and manufacturing methods between facilities can be difficult to execute. Leveraging the Argonaut team makes transitions easier than ever:
• Creation of process documents, converting existing docs to AMS format – raw material specifications, SOPs, master batch records, work instructions, label/carton proofs, pack out instructions, and more.
•Transfer of existing manufacturing process to AMS, including on site training, process equipment installation, and qualification
• Engineering runs at scale
• Validation runs at scale
First article builds
The first production build is unique and customized. Argonaut has the experience to take you through your First article builds, as you move to ongoing production
cGMP Production
Argonaut will manage your ongoing production and deliver your product to you or your end user on time, on budget, with the quality you expect from a premier cGMP manufacturer
Scale up
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 manufacturing and across industries can help your team
Portfolio transfers including long tail SKUs
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.
Previous
Next

Regulatory Importance

Prioritizing quality from day one, the Argonaut Quality Management System is the overarching structure that houses all other systems, including ERP. We continuously build the leading capabilities as your supply chain, manufacturing, regulatory, and third party logistics partner.

Our Credentials

Argonaut’s Quality Management System is compliant to ISO 13485:2016, cGMP, and quality system regulations 21 CFR 820, 21 CFR 210, 21 CFR 211, and Argonaut is FDA registered and CA FDB audited. Government and regulatory agency projects we have hosted include FDA, Japanese PMDA, European QP, BARDA, Health & Human Services, and Project Warp Speed.

Quality is in our DNA

Based on your quality control specifications we can assess a number of factors including: identity, compendial methods, pH, osmolality, viscosity, conductivity, particulates, bioburden, endotoxin, and headspace.

Innovators/ Creators

Stability studies require a dedicated effort across long time periods, often tying up resources for years. Partnering with Argonaut gives you the expertise and capabilities you need, without the headaches of managing chambers, storage conditions, or testing; allowing you to focus on pursuing pre-IND submission, clinical trials, or commercialization.

Smallest to Largest

Whether you’re a small innovative company or a Fortune 100 company, Argonaut works closely in strategic partnership with many of the most well known companies in the industry.  We look forward to you joining these powerful partnerships.

Leaders & Experts

The largest companies know what’s at stake when choosing the right contract manufacturer. Argonaut to outsource new product introductions, long tail/non-core product lines and entire portfolios.

Our Promise and Commitment

Your Goals

We align your target goals with manufacturing requirements to provide a clear roadmap.

Your Process

We will suggest alternative approaches and tap our ecosystem partners to provide you a range of choices.

Our Delivery

Your product is shipped and delivered with finalized cGMP documentation.

Contract Manufacturing Done Right.

Call us at +1 888-834-8892
LIKE YOU, WE ARE MAKERS...
Let's discuss the right solution for your team!

Quality Control

Quality is the key to biotech manufacturing and Argonaut can assist your efforts, from preclinical through commercialization. Our dedicated team, equipment, and expertise supplements yours. (No hyperlink)

  • Analytical method transfer, qualification, and validation
  • Raw material qualification
  • In-process testing
  • Lot release testing
  • Stability studies

Quality Assurance

Preventing defects from entering your product build gives you confidence the standards you establish are being met. Argonaut can help qualify systems and suppliers, inspect reagents or materials, and train staff on risk mitigation.

  • Supplier qualification – questionnaire, on site audit and report
  • Supplier investigations