Your Contract Manufacturer for Diagnostics & Life Sciences
Argonaut provides biotech manufacturing across a variety of needs, from turnkey solutions to a la carte mixes. With cGMP, FDA registration, and ISO 13485:2016 certification we build quality into each step, every time. Over 8000+ sq.ft. of clean room is available (ISO 8) and all operations are integrated into a validated EQM system.
We provide complete supply chain services including supplier evaluation, selection and qualification. Argonaut links your suppliers into a unified manufacturing system providing seamless materials management- while giving you complete visibility.
Want shipping and cold storage? We do that too.
For us manufacturing isn’t routine, it is our priority.
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. Our team can help your team:
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:
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:
There is no one-size-fits-all approach to biotech manufacturing: RUO versus FDA regulated products, pilot scale versus made to order, reagent solutions versus instrument kit. Different scopes have distinct requirements.
From point solutions to turnkey manufacturing, choose the product manufacturing capability to find out how Argonaut supports your operations.
With concept testing finished, it is time to get your new product configured. 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. Our team can help your team:
Bridging skills, technologies and manufacturing methods between facilities can be difficult to execute. Leveraging the Argonaut team with yours 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
Balancing capacity with demand forecasts requires planning and operational flexibility. High mix, low volume products can be particularly problematic. Argonaut handles your cGMP manufacturing requirements- from the routine to the complex:
Bulk formulation and filtration
Filling into tubes, vials, bottles, syringes, cartridges
Shifting gears from liquid to lyophilization formats provides both excellent operational and end-user benefits. Improve product stability, remove cold chain, reduce shipping costs, and lower your carbon footprint by going ambient.
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
From shipping validation studies through pick, pack, and ship, Argonaut can enhance your fulfillment strategies. Want to keep your on-site facilities maximized towards research and development? Free up high-value space using dedicated Argonaut warehousing for storing raw materials and finished goods.
Development of pack out instructions
Pick-Pack-Ship fulfillment program
Product storage at RT, 4C, -20C, -80C
White Papers & Case Studies
Interested in tips and advice from our experiences? Some are big ideas. Others are hard-earned lessons. Check out the white-papers and blogs!
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.
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.
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.
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.