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.

Drug Product Manufacturing UK
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.

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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.

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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.

Frequently Asked Questions (FAQs) About Drug Product Manufacturing

A: Unfortunately we do not offer pharmaceutical lyophilization services at this time. Please refer to our drug products manufacturing page for our full biopharma capabilities.
A: Yes, Argonaut offers validated storage at ambient, +4C, -20C, and -80C.
A: 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.
A: Our VarioSys line has a modular design that enables addition of syringe or vial filling capabilities. Please contact us to learn more.
A: At this time we do not offer drug synthesis. However, we are able to formulate using your supplied API.
A: At this time we do not work with high-potent drugs of any type.
A: Yes, our line uses SKAN isolators.
A:

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

A Contract Development Manufacturing Organization (CDMO), is a company that provides comprehensive services to biotech and pharmaceutical companies related to the development, manufacturing, and testing of drugs and other biotechnology products. CDMOs offer a wide range of services, including supply chain management, technical transfer, engineering development, first article builds, cGMP (current Good Manufacturing Practices) manufacturing, and quality and regulatory services.

There are several reasons why life science & diagnostic companies should consider working with a CDMO:

Expertise and experience: CDMOs possess specialized knowledge and expertise in the field of life science and IVD manufacturing. They are well-versed in the latest technologies, equipment, and regulatory requirements, ensuring that your product is manufactured to the highest quality standards.

Cost savings: By outsourcing life science and IVD manufacturing to a contract manufacturing organization, biotech companies can save on the costs of setting up, maintaining, and operating their own manufacturing facilities. This can free up resources that can be redirected towards research and development, allowing companies to focus on their core competencies.

Flexibility and scalability: CDMOs offer a high level of flexibility and can easily adapt to changing production needs. They can quickly scale up or down according to the client’s requirements, ensuring a seamless transition between different stages of the product lifecycle.

Risk mitigation: By working with a contract manufacturing organization, biotech companies can mitigate the risks associated with life science and IVD manufacturing, such as potential production delays or issues with regulatory compliance. CDMOs have established quality management systems and follow cGMP guidelines, ensuring that the final product meets regulatory requirements.

Faster time to market: CDMOs can help accelerate the product development process by taking care of manufacturing and related services, allowing biotech companies to focus on other aspects of bringing their product to market. This can result in faster time to market and a competitive advantage.

In summary Partnering with a CDMO can provide significant benefits to life science & diagnostic companies working with POCT (Point of Care Testing), IVD (Diagnostics) & RUO (Research Use Only) products, including cost savings, increased flexibility, risk mitigation, and faster time to market. By leveraging the expertise and resources of a CDMO like Argonaut, biotech companies can focus on their core competencies and successfully bring their products to market.

A: A contract manufacturing organization (CMO) is the same as contract development and manufacturing organization (CDMO). The acronym was changed to differentiate it from Chief Medical Officer or Clinical Monitoring Organization.
A: Argonaut offers formulation, vial filling, finishing, and analytical support for the biopharmaceutical industry. Please see below for compatible vials.
A: 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.
A: 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.
A: We use ready-to-use, pre-sterilized nested ISO vials. Currently vials from 2R through 30R are available.
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Main Office
2841 Loker Ave E
Carlsbad, CA 92010

Contract Manufacturing Done Right.

Call us at +1 888-834-8892

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.

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
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