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Argonaut Opens Custom Controls and Standards Facility

Formulation and filling will be performed at a state-of-the-art site in Carlsbad, CA.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Contract manufacturing organization (CMO) Argonaut Manufacturing Services, has launched a new service offering in support of the growing need for custom controls, standards and verification panels. The service of formulating and filling these products will be performed at a newly commissioned, state-of-the-art, standalone facility located in Carlsbad, CA. This site is 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 SOP’s are followed properly for patient samples.
 
The Custom Molecular Controls and Standards service provides organizations, focusing on diagnostics for the regulated markets and RUO assays, a complete solution for not only their commercial products with Argonaut but also controls that match the same high-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, chief executive officer, Argonaut. “Providing another step in the complete solution to our clients contract manufacturing needs was our aim and when combined with our liquid or lyophilization format delivery option, we believe we have enabled a much needed compelling alternative.”
 
The Argonaut Custom Molecular Controls and Standards provides a wide range of solutions including synthetic PCR controls, antibodies, buffers, and markers. Additionally, controls and standards can 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 labor-intensive SOP’s to manufacture their own controls, Argonaut clients can quickly add controls that are specific for their assays,” said Eric Blair, chief operating officer, Argonaut. “With our strength in lyophilization, we think our Custom Molecular Controls and Standards service offers unparalleled opportunities for improving assays by removing saving costs, reducing waste due to shelf-life issues, and simplifying protocols by reducing pipetting and mixing steps.”

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