When working with a CMO/CDMO partner, you need someone who can provide a wide range of solutions to meet your needs. And for those producing research-use-only (RUO), point-of-care (POC) or IVD/companion diagnostics, you want a partner skilled in not only cGMP, but also design for manufacturability (DFM), PFMEA and validation.
Point-of-care testing has transformed the medical field, enabling rapid screening, diagnosis and treatment of patients.
As the leader in providing full turnkey solutions for clients with POC devices and assays, we have the capacity, capabilities, know-how, IP, and processes to help our clients build their POC device efficiently and effectively. Argonaut is committed to bringing point-of-care molecular diagnostics tests to the market faster, better, and more affordably.
When developing RUO products, the entire process can be challenging — from sourcing high quality materials to implementing quality management systems and adhering to good manufacturing practices.
In-vitro diagnostic (IVD) platforms are evolving rapidly around molecular diagnostics, multiplexed formats, automation, and demand for POC technology. While platform value is often dominated by reagents, a full grasp of system (hardware, software, and consumables) architecture and performance is critical to market success.
Companies producing products that are RUO, POC, or IVD/companion diagnostics should invest in their future by standardizing to cGMP; a critical regulation that ensures accurate design, monitoring and control of manufacturing processes and facilities.
Our company is designed around the principal that all applications may at some point be directed to the clinic. As a result, Argonaut offers full cGMP capabilities — cGMP, ISO13485-2016, Med Device 21CFR820 including a complete cGMP supply chain available for your diagnostic or life science kits. From formulation to QC, to kitting and shipping, we handle all your manufacturing needs.
Design for manufacturability (DFM) is an additional engineering practice that ensures the design of a product is easy to manufacture.
Errors in a manufacturing process not only can be costly, but also deadly. By implementing PFMEA, a methodical approach for identifying risks and errors from various sources, you can ensure your manufacturing remains safe and streamlined.
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.