Biotech Manufacturing in the United States

What do you want to learn about first?

Advantages of Manufacturing in the U.S.

We manufacture your pharmaceutical, diagnostic, combination, or research product.

Smooth technology transfer with cGMP and ISO compliance, produced to your requirements.

Reliable Manufacturing Base:

Ethical labor practices
Stable currency
Adherence to environmental and sustainable practices
Alignment with stringent quality control and safety standards

Readily Access the World’s Largest Economy:

Fast delivery of your product
Reduce your carbon footprint with lower transport emissions and energy consumption
Many prefer “Made in America” as a standard of quality
Surge capacity & risk mitigation

Get Your Biotech Product Made In America

Why choose Argonaut

We can get your product manufactured in the United States.

Argonaut is built by industry leaders with decades of experience in cGMP aseptic fill/finish, life science, and IVD manufacturing.

Argonaut’s key differentiators

Our story is one of partnership and innovation. Using your CE Mark or other framework as a baseline, we can help guide you through U.S. regulatory requirements. We only perform manufacturing services, so we will never compete against your products – and we are experts in biotech manufacturing in the United States.

Efficient Product Transfer

Our team has extensive experience in technology and product transfer, from simple to complex projects. Working with your BOM we source either identical or comparable parts and engage our Ecosystem Partners to get the best solution. You are also assigned a dedicated project manager, so communications are seamless.

Quality is Our Core

Prioritizing quality from day one, the Argonaut Quality Management System is the overarching structure that houses all other systems, including ERP. 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.

Risk Mitigation

Armed with advanced automated aseptic fill finish manufacturing equipment, Argonaut can reduce contamination risk, helping ensure the safety and quality of your products at every stage of the manufacturing process.

State-of-the-Art Facilities

Most CDMO’s will say they have state-of-the-art facilities, but few continue to invest in the future of biotech manufacturing in the United States like Argonaut. Our investment in equipment and technology means you don’t have to invest – we did it for you.

Breadth of Manufacturing Services

Get manufacturing that is customized to your needs. Argonaut provides a broad range of operational solutions including:

Aseptic Drug Fill/Finish
Kitting and Assembly for Diagnostics and POCT
Research Use Kit Formulation and Assembly
Lyophilization
Combination Products
Supply chain logistic management
QC Testing (including raw material acceptance)
Regulatory advisory services

How we work at Argonaut

Working Together
Know What to Expect and When

Get peace of mind with transparency & communication

Communication is critical and we will help you understand processes and alternatives

– Vice President Of Clinical Development Operations Boston-based Biotech Company

Frequently Asked Questions

FAQ’s you should know about biotech manufacturing in the United States

Every journey to contract manufacturing is unique. Some biotech companies know, at the start, they want to work with a contract manufacturing organization (CDMO), while others choose to engage a CMO later in the product design process or even after production has started.

These FAQ’s will help you better understand what you need to be considering no matter what stage you are in of early, late, and post-production engagement.

Q: Why should biotech manufacturing be established in the United States?

A: Setting up biotech manufacturing in the United States can strengthen your supply chain, decrease risk, and cross-fertilize innovation between your manufacturing facilities.

Q: What are the key advantages in establishing manufacturing in the United States compared to other countries?

A: Your advantages include stricter quality control, access to research institutions, skilled workforce, regulatory familiarity for US domestic production, and reduced transportation costs.

Q: Why should we use Argonaut, instead of setting up biotech manufacturing in the U.S. ourselves?

A: Argonaut will likely dramatically decrease the time it takes to get your production up and running. We have a skilled workforce, large manufacturing footprint, established CRM, robotics, and established warehousing/logistics. You will save on capital infrastructure while gaining operational flexibility. As a further option, you can engage Argonaut while building out your own operation.

Your Process

Our Delivery

Get a turn-key manufacturing service that works for you.