The Combination Product Manufacturing Experts

Specializing in Services for 
QSR 21 CFR 820, 21 CFR 210, 21 CFR 211




Regulatory Support

Argonaut Combination Product manufacturing

Your CDMO for Combination Products:

Microelectronic, Injectors,

Oral Delivery, Topical System

We have experience with the FDA Office of Combination Products that you need

Our combination product manufacturing services include:

  • Microelectronic dispenser fill finish
  • Oral delivery/topical system fill finish
  • Single entity products
  • Co-packaged products
  • Assembly & packaging in ISO 8 cleanrooms
  • Stability studies
  • Container closure integrity (CCIT)
  • Chemical compatibility testing
  • Terminal sterilization
  • Regulatory support
  • Process validation

GMP manufacturing - specialization:

  • Batch sizes 10 units >10K units
  • Scale-up & process improvement
  • Multi-discipline teams
  • Supply chain management
  • ISO certification, FDB licenses, FDA registered (link to certificates)
  • Full scale analytical quality control support
  • QA/Regulatory support

Take Your Combination Product to the Next Level

Why choose Argonaut

We know how to navigate the complexities of combination products including device-driven FDA QSR 21CFR 820 or drug-driven (CBER/CDER) regulatory frameworks.

Built by industry leaders with decades of cGMP experience in drug fill/finish and device manufacturing.

Argonaut’s key differentiators

Unlike others, Argonaut has a background in both devices and pharmaceutical fill finish. It is this fusion of foundational knowledge and regulatory systems that is key to combination product manufacturing.

Reduce Time to Market

Our in-house expertise and flexible manufacturing lines provide excellent, rapid solutions for your combination product.

Simplified Supply Chains

Argonaut helps simplify your supply chain by consolidating steps in-house. Our purchasing controls are QSR compliant.

Quality Management System (QMS)

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 including Part 4 update, 21 CFR 210, 21 CFR 211, and Argonaut is FDA registered and CA FDB audited (link to certificates).

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

Your Goals

We align your target goals with combination product 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.

Frequently Asked Questions

FAQ’s you should know about outsourcing your combination product manufacturing

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.

A: Yes. We can support manufacturing under guidance of Part 210 and Part 211.
A: Yes, and we have a strong background with Part 4 including:  21 CFR 820.20, Management Responsibility, 21 CFR 820.50 Purchasing Controls, 21 CFR 820.100 Corrective & Preventative Actions, 21 CFR820.170 Installation.
A: We suggest starting with the Combination Products Guidance from the Office of Combination Products (OCP), FDA.
A: Yes, our Bausch+Ströbel VarioSys filling line is paired with SKAN isolators.
A: Our Bausch+Ströbel VarioSys filling line has a modular design that enables the addition of syringe or cartridge filling capabilities. Additionally, we have announced a planned expansion of our drug product fill-finish capabilities, which include an additional filling line that will be validated to produce vials, cartridges, and syringes. Please contact us to learn more.
A: Yes, Argonaut offers validated GMP storage at ambient, +4°C, -20°C, and -80°C. Other storage conditions are available upon request.
A: At this time we do not offer drug synthesis or production of active pharmaceutical ingredients. However, we often formulate bulk drug substance or API for our clients prior to filling.
A: Argonaut can support programs up to and including SafeBridge Category 3, which includes some antibody-drug conjugates (ADCs). Please contact us for an assessment of a specific molecule.
A: Argonaut can support all phases of clinical manufacturing as well as scale-up, validation, and commercial production. Our team has collective experience validating and launching dozens of successful commercial products. If you are interested in working with us to progress from clinical to commercial, please contact us to learn more.

CDMOs play a crucial role in ensuring the quality of the products they manufacture and maintaining compliance with applicable regulations.

To achieve this, reputable CDMOs like Argonaut implement a comprehensive approach that includes the following elements:

Quality Management System (QMS): A robust QMS is the backbone of a CDMO’s quality and compliance efforts. The QMS includes policies, procedures, and guidelines that govern every aspect of the life science and IVD manufacturing process, from raw materials sourcing to finished product release.

Compliance with Good Manufacturing Practices (GMP): CDMOs adhere to GMP guidelines and other relevant industry standards to ensure that products are consistently manufactured according to quality requirements. GMP guidelines cover various aspects of the production process, including personnel qualifications, equipment maintenance, and record-keeping.

Regulatory expertise: CDMOs employ experienced regulatory affairs professionals who are knowledgeable about local and international regulations, industry standards, and best practices. These professionals help ensure that the CDMO stays up-to-date with the latest regulatory changes and maintains compliance throughout the life science or IVD manufacturing process.

Regular audits and inspections: CDMOs undergo regular audits and inspections by both their clients and regulatory authorities to verify that they maintain compliance with applicable regulations and quality standards. These inspections help identify potential issues and ensure that corrective actions are taken promptly.

Employee training: CDMOs invest in continuous training and education for their employees to ensure that they have the necessary skills and knowledge to maintain quality and compliance. This includes training on relevant regulations, industry standards, and best practices.

Quality control and assurance: CDMOs implement rigorous quality control (QC) and quality assurance (QA) processes throughout the life science and IVD manufacturing process. QC involves testing and monitoring of raw materials, intermediate products, and finished products to ensure that they meet established specifications. QA focuses on the overall quality management system and helps identify and address potential issues before they impact product quality.

Documentation: CDMOs maintain thorough and accurate documentation of their life science and IVD manufacturing processes, quality control results, and compliance efforts. Proper documentation is essential for demonstrating compliance with regulations and facilitating audits and inspections.

Continuous improvement: CDMOs are committed to continuous improvement in their quality and compliance efforts. They regularly review their processes, systems, and performance to identify areas for improvement and implement necessary changes.

By implementing these measures, reputable CDMOs like Argonaut can ensure that they consistently deliver high-quality products while maintaining compliance with applicable regulations. Partnering with a CDMO that prioritizes quality and regulatory compliance can provide peace of mind and help minimize potential risks associated with life science or IVD manufacturing.

A: Our leadership team has extensive industry experience and has backgrounds at leading drug product manufacturers including Aji Bio-Pharma (Althea), ThermoFisher (Patheon), Vetter, Allergan, and more.
A: Argonaut has a full service analytical lab supporting for in-process, release, and stability testing. Please see our QC page for a more comprehensive description.

Your Process

Our Delivery

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

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