A Trusted CMO for Drug Fill/Finish, In-vitro Diagnostic (IVD), and Life Science Kits: Argonaut Manufacturing Services
The Silicon Review
Argonaut Manufacturing Services is a prominent FDA-registered cGMP contract development and manufacturing organization (CDMO), offering specialized manufacturing and supply chain solutions tailored for biopharmaceutical and diagnostic companies. With a focus on aseptic drug fill/finish, Argonaut boasts state-of-the-art automated equipment that ensures high-yield filling of sterile injectable drugs, including biologics, peptides, small molecules, and vaccines. Their diagnostic manufacturing capabilities are equally impressive, featuring proprietary lyophilization technology and a comprehensive array of kitting options. Each project is bolstered by extensive analytical quality control services, encompassing warehousing and global shipping logistics, ensuring seamless operations from production to delivery. Catering to the needs of innovators in the biopharma, life science, and molecular diagnostics sectors, Argonaut Manufacturing Services provides a broad spectrum of flexible solutions to meet diverse outsourcing requirements. The company's mission is deeply rooted in improving the human condition. By fostering a culture that attracts exceptionally talented individuals and drives the innovation of superior products and services, Argonaut helps its partners achieve their health-related objectives and exceed their goals.
The inception of Argonaut Manufacturing Services was driven by a desire to create a better solution for contract manufacturing. The founders, having held executive leadership positions at industry giants such as Althea, Thermo Fisher, Affymetrix, Allergan, and Ion Torrent, brought with them a wealth of experience and a keen understanding of the industry’s needs. They ventured out to build Argonaut, a company designed to provide what they themselves sought in a manufacturing service – a commitment to "Contract Manufacturing, Done Right." Argonaut’s team is a blend of highly experienced professionals who have been in their customers' shoes. This shared background enables them to design services and solutions that meet the highest standards, with a clear focus on customer needs and satisfaction. Their collective expertise allows them to empathize with their clients, ensuring that every aspect of their service is tailored to support and enhance their clients' success.
In the competitive landscape of biopharmaceutical and diagnostic manufacturing, Argonaut stands out with its dedication to quality, innovation, and customer-centric solutions. Their state-of-the-art facilities and advanced technologies ensure that they can meet the most stringent regulatory requirements while delivering products that meet the highest quality standards. Moreover, Argonaut’s commitment to full-spectrum support—from initial development through to manufacturing, quality control, and distribution—provides a comprehensive solution for companies seeking to outsource their manufacturing needs. This integrated approach not only enhances efficiency but also ensures that clients can rely on a single, trusted partner for all their manufacturing requirements. Argonaut Manufacturing Services represents the pinnacle of contract manufacturing in the biopharmaceutical and diagnostic industries. Their combination of cutting-edge technology, experienced leadership, and unwavering dedication to quality and customer service positions them as a leader in the field, ready to meet the complex needs of their clients and contribute to the advancement of global health.
Aseptic Fill Finish Manufacturing
Argonaut Manufacturing Services is a leader in contract aseptic fill finish manufacturing, delivering world-class solutions through cutting-edge technology and a dedicated team of experts. Their commitment to flexibility and quality sets them apart in the industry, ensuring that each project is handled with precision and care to meet the unique needs of their clients.
Comprehensive Aseptic Fill Finish Manufacturing
Argonaut provides comprehensive contract aseptic fill finish manufacturing services for a wide range of drug products. Their state-of-the-art facilities and continuous investment in advanced technology secure unparalleled quality, mitigate risks, and enhance speed to market. This commitment is evident in their high-performance fill finish services, which include formulations, filling, sterile filtration, and assay development.
Advanced Fill Finish Capabilities
Argonaut's fill finish capabilities feature:
These advanced capabilities ensure high yield, reduced contamination risk, and consistent product quality.
Diverse Drug Products
Argonaut's expertise covers a broad spectrum of drug products, including:
Quality and Regulatory Excellence
Quality is at the heart of Argonaut's operations. Their rigorous quality management system ensures the highest standards from raw material sourcing to final product release. Argonaut's regulatory expertise supports complex programs from clinical stages through to commercial production, complying with global regulatory requirements. They hold ISO 13485:2016 certification and adhere to cGMP and quality system regulations (21 CFR 820, 21 CFR 210, 21 CFR 211), with FDA registration and CA FDB audits.
State-of-the-Art Equipment
Argonaut continually invests in the latest aseptic fill finish manufacturing technology to reduce risk and enhance manufacturing flexibility. Their process utilizes a Bausch+Ströbel VarioSys filling line and SKAN technology, which provides near 100% yield and minimizes particulate risk with single fluid path filling.
Stability Testing and Compliance
Argonaut offers comprehensive stability testing in cGMP validated environments, including real-time, freeze-thaw, pre-clinical to commercial stages, and ICH compliant stability studies. Their experienced quality and regulatory team has successfully hosted audits from the FDA, PMDA, global clients, and qualified persons from the EU and UK.
Broad Vial and Fill Volume Range
Argonaut accommodates a wide array of vial sizes and fill volumes with ready-to-use RTU vials ranging from 2R to 30R and dosing ranges from 0.25ml to over 30ml. Crimp sealing is performed under ISO 5/Grade A air in a separate cabinet to ensure sterility.
Efficient Shipping and Storage Logistics
Argonaut provides drop-ship distribution and storage solutions, including ambient, refrigerated (2-8°C), and frozen (-20°C, -80°C) conditions with temperature and shock monitoring for global shipping and distribution.
Tech Transfer and Program Management
Argonaut's team develops all necessary documentation, from SOPs to master batch records, to support engineering and validation builds, ensuring smooth tech transfer and efficient program management.
Strategic Partnership
Argonaut prides itself on being more than just a CDMO. By fostering open communication and collaboration, they tailor their aseptic fill finish manufacturing services to meet specific client needs, creating value that goes beyond product quality. Their agile manufacturing capabilities allow them to accommodate changing volumes and formulations without sacrificing quality or timelines.
Risk Mitigation and Continuous Improvement
Argonaut's advanced automated aseptic fill finish manufacturing equipment significantly reduces contamination risk, ensuring product safety and quality at every stage. Their ongoing investment in state-of-the-art facilities and technology ensures they remain at the forefront of the industry, providing their partners with a reliable and forward-thinking manufacturing solution.
Argonaut Manufacturing Services combines cutting-edge technology, rigorous quality standards, and a customer-centric approach to deliver unparalleled aseptic fill finish manufacturing services, making them a trusted partner in the biopharmaceutical and diagnostic industries.
Meet the leader behind the success of Argonaut Manufacturing Services
Wayne Woodard, CEO and Board Member
With 28 years of management experience in operations, supply chain and general management, Wayne Woodard’s primary focus (in three different industries) has been on building global operations capabilities with particular emphasis on working with external manufacturing services companies. Wayne most recently worked at Thermo Fisher/Life Technologies through its Ion Torrent acquisition. He previously worked at Affymetrix, Electroglas and Ridge Technologies. Wayne began his career in manufacturing at Sun Microsystems. Wayne focuses intensely on execution and detail, which is why he also bottles his own wine.