Your Contract Manufacturer for Drug Products

Access the world’s leading fill and isolator technologies with an expert team at your side. Customize the manufacturing solution you need without investments in capital equipment, staff, or logistics. Equipped with advanced robotics, our automated fill line is specially designed to maximize product yield while minimizing the risks associated with operator intervention.

Formulation
Fill
Finish
Analytical
Contact Us to Have Your Drugs Made Right

Flexible Filling Capabilities for Rigorous Demands

drug product manufacturing fill line

Argonaut’s drug product manufacturing services provide the expertise, flexibility, compliance, and speed you need to get your parenteral to clinics around the globe. Protect your drug product with our state-of-the-art line, built on fully-enclosed SKAN isolator technology.

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Advantages
Capabilities & Specs
Support Services

We Support Your Team – Pre-Clinical to Phase III

Aseptic manufacturing is a core competency at Argonaut. With prior backgrounds at leading drug product manufacturers including Ajinomoto Bio-Pharma Services, Thermo-Fisher, Allergan and more, we have the experience you need for fill and finish applications.

Click on each stage to find out more:

drug product manufacturing analytical transfer

Analytical Transfer

We work with you to develop a well-defined transfer plan with emphasis on communication. Using single points of contact, we begin with a pre-transfer meeting and then establish a cadence of updates. Required resources and timeline are determined next. With agreement on the types of testing and training in place, multiple lots are evaluated and a transfer report generated. Analytical transfer is not a checkbox function at Argonaut; we take the time to make it right.

drug product manufacturing formulation

Formulation

We will prep your API to your specifications. Argonaut uses single-use technology for formulation and filling to protect your product. Following formulation the bulk drug is rendered sterile by passing it through two sterilizing filters (0.2 µM).

drug product manufacturing fill

Fill

Our Bausch + Ströbel VarioSys fill line with SKAN isolator technology reduces risk of particulate contamination and of human intervention. We safeguard your drug product with SKAN barrier isolation, single-use disposable fluid path, and pre-sterilized glass vials. ADVANCEDfill technology virtually eliminates product loss during start-up and end of production.

  • Dosing ranges from 0.25ml to 30+ml.
  • Run rates to 3,600 vials per hour
  • Ready-to-use pre-sterilized vials: 2R, 6R, 10R, 20R, 30R
  • Stäubli robotic lid and liner removal and denester
  • Peristaltic pumping
  • Call us for syringe and cartridge applications

drug product manufacturing fill line

drug product manufacturing finish

Finish

Argonaut offers labeling and packaging services following filling activity of your drug product.

drug product manufacturing quality control

Quality Control

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. We have a full range of instruments ready to evaluate the quality of your product.

drug product manufacturing HPLC

drug product manufacturing quality assurance

QA / Regulatory

With MasterControl as our enterprise quality management system (eQMS), we have the infrastructure to support regulatory filings. Our team has extensive experience supporting FDA and EU drug submissions.

drug product manufacturing shipping

Shipping & Storage

With our 31,000 sq.ft. facility including warehouse space, expandable walk-in 4°C refrigerator, -20°C freezer, -80°C freezers, back-up generator and 24/7 security, we keep your product safe. Upon release we will ship to your required destination, worldwide.

drug product manufacturing storage

White Papers

Interested in tips and advice from our experiences? Some are big ideas. Others are hard-earned lessons. Check out the white papers and blogs!

Linking Pharma Manufacturing: CDMOs, Blockchain & Distributed Ledger Technologies (DLT)

The term blockchain is most often associated with cryptocurrencies such as Bitcoin, but the technology and its implications could have a more far-reaching impact on other industries including pharmaceutical manufacturing.

Contract drug manufacturing organizations (CDMOs) and pharmaceutical developers could realize tangible benefits by implementing a variant of blockchain termed “Distributed Ledger Technology” (DLT).

Learn more about DLTs and Argonaut by downloading the white paper.

(Click to preview first page)

Download Full White Paper

FAQs

Argonaut offers formulation, vial filling, finishing, and analytical support for the biopharmaceutical industry. Please see below for compatible vials.

Our team comes from backgrounds at leading drug product manufacturers including Aji Bio-Pharma (Althea), ThermoFisher, Allergan, and more. Our COO Chris Duffy and VP of Regulatory & Quality Stacy Sutton are well known in the industry.

Argonaut operates a custom-designed, state-of-the-art Bausch + Ströbel VarioSys line with SKAN isolator technology. Our line utilizes B+S’s ADVANCEDfill technology to maximize yield, and our isolator-based filling eliminates the need for personnel intervention.

Argonaut offers full service analytical support, please see our QC page for a more comprehensive description:

Yes, our line uses SKAN isolators.

Argonaut plans to add commercial support in the future, and our equipment and facility are commercial-ready. If you are interested in working with us to progress from clinical to commercial, please contact us to learn more.

Yes, Argonaut offers validated storage at ambient, +4C, -20C, and -80C.

At this time we do not work with high-potent drugs of any type.

Our VarioSys line has a modular design that enables addition of syringe or vial filling capabilities. Please contact us to learn more.

We use ready-to-use, pre-sterilized nested ISO vials. Currently vials from 2R through 30R are available.

At this time we do not offer drug synthesis. However, we are able to formulate using your supplied API.

While Argonaut is a leading supplier of lyophilization services for the life sciences industry, at this time we do not offer aseptic lyophilization. We plan to add these capabilities in the future, please contact us to learn more.

Latest Drug Product Manufacturing News and Blog

  • BIO 2019

Our top picks for BIO International 2019

May 28th, 2019|0 Comments

The 2019 BIO International conference is only one week away! Here at Argonaut, our team is preparing for a week filled with partnership meetings and exciting talks. This year a major conference focus is on rare diseases and precision medicine. With t [...]

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Like you, we are makers.

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