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Choosing the right IVD (in vitro diagnostics) manufacturer is a pivotal decision that can significantly impact your organization’s success in the highly competitive molecular diagnostics industry. With multiple IVD manufacturers to choose from, as well as numerous suppliers for assay materials, you may be considering one manufacturer for initial formulation, another for final formulation, and potentially even a third for assembly and packaging. It’s crucial to choose IVD manufacturers who can provide the necessary capabilities for formulation, filling, testing, and storage/distribution. If your organization has a large commercial footprint, you may also want manufacturing redundancy from a primary and secondary site.
Optimize logistics with local IVD manufacturers: Choose IVD manufacturers that are proximal to central logistics hubs. As an example, your IVD manufacturer should not be reliant on one airport- they should be able to drive freight to a second large airport within 2 hours. Manufacturers need quick specialized support for HVAC, water purity, isolators, freezers, or robotics technicians, so the facilities should not be rural.
Select IVD manufacturers that use current technologies, for example lyophilization: Lyophilizing your IVD assay removes cold chain logistics and shipping temperature challenges for both you and your customers.
Mitigate supply chain risks: Partnering with diagnostics manufacturers who have robust, mature supply chains helps safeguard your production process against disruptions. This ensures consistent, reliable delivery of your products, even during supply chain disruptions and market instability.
Regulatory compliance: Choosing IVD manufacturers with strong regulatory knowledge and experience ensures your products meet all necessary standards. This reduces the risk of compliance issues that could delay your product launch and helps you navigate complex regulatory landscapes with confidence.
Argonaut has specialized services for technical transfer of IVD diagnostic products, with years of experience.
We manufacture in all commercial phases: from pre-launch engineering builds to flexible on-demand production.
Our teams can hand-fill when white-glove attention is needed, or we can use our robotic systems as scale demands increase.
Argonaut adheres to the highest quality standards including: ISO13485:2016 and cGMP
Argonaut is FDA audited and we support a wide range of products under 21 CFR 820.
Argonaut promises to suggest alternative approaches to provide you a range of choices.
Argonaut is a recognized leader in lyophilization with a wide service selection including cakes, powders, beads, and dots.
