Aseptic Fill Finish Manufacturing Services

Access the world's leading aseptic fill finish manufacturing technology with a team of experts at your side.

Flexibility & Quality in manufacturing solutions are Argonaut’s differentiators.

Argonaut provides full service contract aseptic fill finish manufacturing for drug products. We ensure your project’s success by continually investing in cutting-edge technology and equipment, a commitment that secures your future by fostering unparalleled quality, risk mitigation, and efficient speed to market.

High Performance Fill Finish

Services include formulations, filling, sterile filtration, and assay development. Our state-of-the-art aseptic fill finish manufacturing capabilities feature: 

  • Near-zero line loss
  • 100% in-line weight checks
  • Single-use fluid paths
  • 0.25ml to 30+ml dosing ranges
  • 2R to 30R vial formats
  • Up to 3600 vials per hour
  • ISO 5/Grade A conditions in isolator
  • Utilization of the highest quality RTU components
  • Segregated crimping to minimize particulate risk

Types of Drug Products

  • Biologics – mAb, proteins, plasmids, enzymes, etc.
  • Small and intermediate molecules – peptides
  • Oligos (ASO, mRNA, siRNA, gRNA, etc.)
  • Molecules requiring aseptic formulation
  • Vaccines – adjuvanted vaccines, protein-based vaccines, multivalent vaccines
  • Diluents, adjuvants, placebos

Quality and Regulatory Services

Our commitment to quality is not just a statement; it’s a way of life at Argonaut. We have implemented a rigorous quality management system that spans every aspect of our organization, from sourcing raw materials to the final product release.

State-of-the-Art Equipment

We invest in the latest aseptic fill finish manufacturing technology and equipment to reduce risk and improve manufacturing flexibility. Argonaut’s state-of-the-art filling process utilizes a Bausch+Ströbel VarioSys filling line and SKAN technology. Learn more here.

Get near 100% yield and reduced particulate risk with single fluid path filling.

Stability Testing

cGMP validated environments. Real-time, freeze-thaw, pre-clinical to commercial.
In-process testing. ICH compliant stability studies. Final product release testing. Stability storage & testing.

Compliance

Our experienced quality and regulatory team understands global regulatory requirements. Our team has hosted successful audits from US and ROW including FDA and PMDA, global clients, and qualified persons from EU and UK.

Quality Management Systems

ISO 13485:2016, cGMP, and quality system regulations 21 CFR 820, 21 CFR 210, 21 CFR 211. Argonaut is FDA registered and CA FDB audited. EU-cGMP Annex 1 compliant.

Wide array of vial sizes and fill volumes

Ready to use RTU vials: 2R, 6R, 10R, 20R, and 30R.
Dosing ranges from 0.25ml to 30+ml.
Crimp sealing under ISO 5/Grade A air in separate cabinet.

Shipping / Storage Logistics

Drop-ship distribution.
Ambient, refrigerated (2-8°C), and frozen (-20°C, -80°C).
Temp/shock monitoring.
Global shipping and distribution.

Tech Transfer and Program Management

We develop all docs, from SOPs to master batch records to deliver your engineering and validation builds.

Take Your Drug Product Aseptic Fill Finish Manufacturing to the Next level

Why choose Argonaut

We’ve had to navigate journeys just like yours.

Argonaut was built by industry leaders with decades of cGMP experience in aseptic fill finish manufacturing.

Argonaut’s key differentiators

Our story is one of partnership and differentiating where it matters most. We deliver the highest standards of quality with greater speed to market and reduced risk, while minimizing your capital expenditure.

Prioritizing your unique needs

By fostering open communication and collaboration with our clients, we’re able to tailor our aseptic fill finish manufacturing services to meet your specific needs and create value that goes beyond just product quality. We’re not just a CDMO, we’re your strategic partner, committed to helping you succeed.

Agile Manufacturing

We engineer the ability to increase production capacity to meet your growing (or even shrinking) demands. Our agile aseptic fill finish manufacturing capabilities can easily accommodate changing volumes of product or different formulations without sacrificing quality or timeline. You can rely on Argonaut to meet your expanding production needs without having to invest in additional infrastructure.

Risk Mitigation

Armed with advanced automated aseptic fill finish manufacturing equipment, Argonaut can reduce contamination risk, helping ensure the safety and quality of your products at every stage of the manufacturing process.

Quality and Regulatory

It’s important our partners understand our unwavering commitment to Quality and Regulatory. Quality is not merely a statement for us; it is ingrained in every aspect of our operations. 

State-of-the-Art Facilities

Most CDMO’s will say they have state-of-the-art facilities, but few continue to invest in the future like we do. Our investment in equipment and technology means you don’t have to. Read more about our aseptic fill finish manufacturing line by clicking hot spots on the image below.

Click hot spots to learn more

Argonaut’s Bausch+Ströbel VarioSys filling line paired with a SKAN isolator utilizes the highest quality ready-to-use (RTU) vials in a variety of sizes. Using high quality primary packaging components reduces cosmetic defects and glass particulates that can occur in lower quality vials.

Argonaut utilizes pre-sterilized vials in a nest & tub configuration. A pair of robotic arms removes the adhesive lid on each tub, followed by the tub liner covering the vials. Vials are then de-nested onto the filling line to avoid human intervention and eliminate glass to glass contact.

Argonaut has carefully optimized tubing lengths and diameters to virtually eliminate line loss and dead volume, resulting in extremely high product yields.

The Bausch+Ströbel VarioSys performs 100% non-destructive in-line weight checks, resulting in maximum yield and extremely consistent fill volumes.

Filled and stoppered vials are crimped in a separate isolator compartment. This spatial segregation from the vial filling process helps avoid potential particulate intrusion due to crimping.

Environmental monitoring (EM) activities are integrated into the line to avoid operators interfacing with multiple pieces of equipment.

Argonaut Aseptic Fill Finish Manufacturing Process

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Filling station in action

aseptic fill finish manufacturing
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Filling and gas overlay station and stopper placement in action

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Cap crimping station in action

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

Designed to Deliver

Our integrated project management ensures you have a dedicated specialist by your side, guiding you from project initiation to production. With expertise in aseptic fill finish manufacturing, our project managers serve as your advocate, ensuring on-time delivery of your product while maintaining constant communication and providing finalized cGMP documentation.

Frequently Asked Questions

FAQ’s you should know about outsourcing your Aseptic Fill Finish Manufacturing

Every journey to contract aseptic fill finish manufacturing is unique. Some organizations know, at the start, they want to work with a contract manufacturing organization (CDMO), while others choose to engage a CDMO later in the process or even after production has started.

These FAQ’s will help inform you about aseptic fill finish contract manufacturing.

A: Argonaut offers formulation, vial filling, finishing, labeling and analytical support for the biopharmaceutical industry. Please see our drug product manufacturing page for more information on the services and formats we support.
A: Argonaut operates a custom-designed, state-of-the-art Bausch+Ströbel VarioSys line with SKAN isolator technology. Our line utilizes Bausch+Ströbel’s ADVANCEDfill technology to maximize yield and minimize line loss. Our isolator-based filling virtually eliminates the need for human intervention.
A: Yes, our Bausch+Ströbel VarioSys filling line is paired with SKAN isolators.
A: We use ready-to-use, pre-sterilized nested ISO vials. Argonaut supports vial sizes from 2R through 30R.
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: We do not offer pharmaceutical lyophilization services for injectable products at this time. Please refer to our drug products manufacturing page for a full list of our fill-finish capabilities.
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.
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: 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.
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.

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