Field note 00137.7749 N / 122.4194 W

Manufacturing the assays you designed.

A US based contract manufacturer for diagnostics and life sciences. Reagent through finished product, under one roof, on a timeline your customers will actually tolerate.

StageStealth

BasedSan Francisco

CapacityCommercial scale

IntakeBy introduction

01 / Thesis

Domestic capacity, without the wait.

Every diagnostics team we talk to is stuck between two bad choices.

Option one is overseas. Lower cost on paper, but quality risk, tariff exposure, and supply chains that break when anything moves.

Option two is US capacity that is either booked out to pharma for eighteen months or too small to scale with you past a validation run.

We are building the third option. Same roof, same team, from reagent kits through final pack. Feasibility in days instead of months, because the answer should not take longer than the project.

02 / Scope

What we make.

A / 01Reagent manufacturingcGMP reagent production for IVD and research use. Buffers, enzymes, antibodies, controls.

A / 02FormulationProcess development and scale up. From bench recipe to reproducible batch.

A / 03Fill and finishLiquid and lyo, vials and cartridges. Clean room capacity with full environmental monitoring.

A / 04LyophilizationCycle development, scale transfer, commercial lyo runs for shelf stable reagents and kits.

A / 05Kitting and packFinal assay kits assembled, labeled, and released. Worldwide cold chain on exit.

A / 06Drug device combinationCombination products where assay chemistry meets a physical device. Niche machinery welcome.

03 / Who

Teams we are built for.

01Clinical diagnosticsmolecular, immunoassay, POC

02In vitro diagnosticsClass I through III

03Life science toolsresearch reagents, kits, controls

04Emerging platformsnovel chemistries and workflows

05Combination productsassay plus device

We work with a small set of partners at a time. Early stage teams carrying a design freeze through their first commercial lot, and established IVD businesses that need a second source they can actually rely on. Select partners only.

04 / Intake

Partner with us.

If there is a program you want built in the US, tell us the scope.

We read every note. If there is a fit, someone from the team will reach back within two working days. No newsletters, no drip, no calendar pitches.