Controls and Standards in a Dedicated cGMP facility

Get controls that integrate easily into your assay – worry and risk free of contamination. Whether you produce your own Controls or partner with a Controls expert manufacturer or one of Argonauts ecosystem partners that produce Controls, Argonaut will fill and kit your Controls in a separate 10,000 sq ft. space dedicated to Controls including positive Controls. Argonaut can package Controls in liquid, lyophilized, or dried down formats.

Turn-key Solutions
Argonaut is responsible for supply chain
Dedicated Facility
10,000 Square ft.
cGMP Manufacturing
ISO 13485:2016 and validated EQM system

Easy Integration

Argonaut Manufacturing Services receives and handles your custom controls and standards with the quality and precision you expect of a demanding cGMP manufacturer. Designed for RUO, regulated markets, and Companion Diagnostics assays, we repackage custom quality Controls that span the product cycle from development through end-user run controls.

Examples include positive controls, full-process controls, instrumentation, regulatory standards, and synthetic nucleic acids for purification, amplification, and detection.

These kitted Controls are now ready to be included in your RUO or Diagnostics kits. Argonaut can package just your Controls, or manufacture your Controls and kits and finalize them in a final kitting format. All this worry free of any contamination.

Custom Solutions for your Assay

Argonaut takes your custom controls and provides custom solutions for  filling and kitting your custom control bulks. Argonaut will fill, lyophilize (optional) and kit following types of  controls to include:

  • Sensitivity/Specificity
  • LoD/LoQ/Dynamic Range
  • Inclusivity/Exclusivity
  • Linearity/Accuracy
  • Verification/Validation
  • Run Controls
  • Panels
  • Internal Quality Controls (QC/QA)
  • Post-Market Surveillance
  • And More

How it Works

Step 1

Design your controls or qualify your controls vendor

Step 2

Contract Argonaut to manufacture your kits, and/or kit and package your controls.

Step 3

Argonaut will do all the work to order your controls, fill the vials, and package into final kits.

Argonaut will not design or manufacture the controls. Argonaut will be responsible for ordering, filling, and kitting your controls in a dedicated facility for controls. Argonaut can also manufacture your kits in our main reagents manufacturing site and then combine your controls with your reagents kit as a full turn key service. Argonaut additonally can provide third party logistics, globally shipping to your facility or we can act as distribution center for shipping to your clients

State-of-the-art Manufacturing

Argonaut procures your controls from your qualified vendor and then fills and kits your controls into a final package in a dedicated facility. All processing of your controls is done in a stand-alone facility in Carlsbad, CA. This 10K sq. ft. facility is separated from other Argonaut manufacturing/production to ensure no cross contamination. The facility features:

  • Nucleic acid handling enclosures
  • FDA registration
  • ISO 13485:2016 certification
  • Validated EQM (Electronic Quality Management system)
  • Liquid, Lyophilized, or dried-
    down controls

Repackaged, Reintegrated Production

What we mean by this is Argonaut will work with your controls manufacturer to purchase your custom controls in bulk and then re package and re-integrate into your final controls and reagents kits. This is all done in an ISO 13485-2016 cGMP facility under quality systems control and manufacture in a dedicated facility to the highest exacting quality standards. Your clients will be confident in the controls they receive. Argonaut provides seamless end-to-end production for your controls and standards including:

  • Formulation/Mixing
  • Lyophilization
  • Dispensing
  • Labeling
  • Kitting
  • Packaging
  • Fulfillment
Control types

Liquid

Tried and trusted liquid formats:

  • Any size volumes or tubes/plates required
  • Dilutions from bulk if needed

Lyophilized

Transitioning your controls and standards from liquid to LyoDose™ beads or powder can give your team significant advantages:

  • Simplified end-user protocols
  • Reduced cold-chain costs
  • Extended shelf-life, preventing obsolete inventory
  • Cutting waste by reducing carbon footprint (Green Initiatives)

Dried down

Dried down into plates, tubes, strips, or custom formats:

  • Available to dry down on to swabs
  • Custom formats available

White Papers & Case Studies

Contract Manufacturing Done Right.

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