Argonaut Manufacturing Services opens custom controls & standards facility

The CMO has designed the new service to alleviate manufacturing challenges associated with positive controls and nucleic acid templates

Formulating and filling these products will be performed at a new standalone facility in Carlsbad, California.

The company said the site has been designed to alleviate many of the concerns expressed with the manufacturing challenges associated with positive controls and nucleic acid templates.

Controls and standards are used regularly by innovators to verify instruments, reagents, and diagnostic tests to ensure standard operating procedures (SOPs) are followed properly for patient samples.

The Custom Molecular Controls and Standards service provides organizations focusing on diagnostics for the regulated markets and RUO (research use only) assays, a complete solution for their commercial products with Argonaut and controls that match the same quality standards that Argonaut Manufacturing Services provides.

“This service offering has been widely requested by our clients in every market from Point of Care device makers to platform companies,” said Wayne Woodard, CEO of Argonaut.

The CMO's new offering provides a wide range of solutions including synthetic PCR controls, antibodies, buffers, and markers. Controls and standards can also be lyophilized to both extend shelf-life and improve protocols.

Rather than being restricted to off-the-shelf controls or putting in the capital equipment and labour-intensive SOPs to manufacture their own controls, clients can quickly add controls that are specific for their assays.

Eric Blair, COO of Argonaut, said that with the company's strength in lyophilization, its Custom Molecular Controls and Standards service offers opportunities for improving assays by reducing waste due to shelf-life issues, and simplifying protocols by reducing pipetting and mixing steps.