Access the world's leading Fill/Finish technology with an expert team at your side.
Near 0
Line loss
5 vial
Configurations
Up to 3,600
Vials per hour
8 wk release
From drug substance receipt
100%
Weight checks
ISO 5
Isolator
0.25ml-30ml+
Dosing Ranges
100-30,000+
Batch Sizes
24-48 hrs
Fast track proposals
Phase I - Commercial
Small Batch Commercial

Argonaut Manufacturing Services uses state-of-the-art equipment and technologies to fill and finish your  valuable product at near 100% yield. Our fill/finish line includes single-use minimal fluid paths.

NEAR

100%

YIELD

SKAN isolator, ready-to-use (RTU) pre-sterilized vials, automated denester, in-line non-destructive weight checks, and nitrogen gas overlay. You get the most out your API with reduced risk from particulates and human intervention.

Argonaut Drug Product Manufacturing Fill Process

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Filling station in action

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Filling and gas overlay station and stopper placement in action

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Cap crimping station in action

Integrated Project Management

With you at every step

Your team is assigned a specialized project manager from project initiation to on-going production. They help you drive efficiencies by facilitating communication and developing a well-organized project plan.

Designed to deliver

The project managers at Argonaut have experience in all aspects of the business and act as your advocate. They are here to make sure you get the right product at the right time, staying in touch with you at every step.

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.

Stability Studies

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.

Compliance

Staying current on both FDA and ICH and all applicable global regulatory guidelines is a challenge. Argonaut’s stability team can help keep you in compliance and leverage cGMP programs to support your effort in establishing expiry dating for your intermediates and finished products.

Capabilities

We can satisfy regulatory requirements utilizing real-time, accelerated and freeze- thaw studies. With Argonaut’s fully equipped lab, a diverse range of assessments and methodologies can be engaged- from core characteristics to purity, identity, and potency parameters.

Streamline your Project

Take advantage of our Ecosystem Partners for seamless project handoffs, from drug substance development to instrument design and engineering.

Superior Project Management

Your dedicated Argonaut Project Manager helps coordinate and transition your project with our Ecosystem Partners.

Capabilities & Specifications

Argonaut offers a wide array of vial sizes and fill volumes to choose from:

  • Ready to use pre-sterilized vials: 2R, 6R, 10R, 20R, and 30R.
  • Dosing ranges from 0.25ml to 30+ml.
  • Run rate up to 3,600 vials per hour.
  • Crimp sealing under ISO 5 air in separate cabinet.
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