Contract Drug Product Manufacturing- Argonaut. Access the world's leading pharmaceutical Fill/Finish technology with an expert team at your side.

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 Drug Product 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.

Every drop of your biologic filled for near 100% yield.

Disposable components of the precision automated filler and a minimal fluid path results in industry hold volumes <50 ml. Combined with non destructive 100% weight checks which enable under filled vials to be re-filled to accurate volumes and start up & stop mode, the system utilizes practically every drop yielding near 100% of the Biologic being filled.

Combined with RTU components the result is near 100% yield of vials even with fill volumes down to 0.25 ml fills

Bausch + Strobel

Bausch + Ströbel VarioSys SKAN isolator for near 100% yield

Our isolators provide an aseptic environment, protects the operators and your product reliably. With robust features, the most modular and flexible system on the market is provided.

Automation Yield

Automation
for near 100% yield

The innovative and highly flexible VarioSys® production system for biotech and pharmaceuticals is essentially a combination of two elements: an isolator made by SKAN and machine modules made by Bausch+Ströbel. The system has been designed to provide utmost flexibility in the production of medications by exchanging modules. This design allows for a qualified robust sterilization of the filling environment, elimination of operator intervention during filling and extremely well controlled environmental aseptic conditions during filling.

Ready-to-use
for near 100% yield

RTU vials enable near zero rejects due to three factors-
First, the highest quality pre strerilized glass provides the best vial ready to use directly from the manufacturer. Second, each vial is nested and won’t be rejected due to blemishes from transportation (i.e glass vials rubbing next to each other that creates a blemish). Third, it’s ready for robotics to be loaded in to fill ISO5-Fill isolator

Argonaut Drug Product Manufacturing Fill Process

Filling station in action

Filling and gas overlay station and stopper placement in action

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.

ABOUT

SERVICES

RESOURCES

CONTACT US

Main Office
2841 Loker Ave E
Carlsbad, CA 92010

Contract Manufacturing Done Right.

Call us at +1 888-834-8892