Scale diagnostics consumables with precision that holds at volume

LSO provides reagent packaging and manufacturing services — precision dispensing, blister packaging, pouch filling, and controlled-environment handling. We do not formulate reagents. You provide the formulated reagent; we handle the filling, packaging, and assembly into your final consumable format. Our controlled environments (temperature, humidity, cleanroom class) are designed to maintain reagent stability throughout the packaging process.

Fill accuracy depends on your reagent chemistry and format, but our validated dispensing systems are designed to maintain tight tolerances from pilot through commercial volume. During process development, we establish fill parameters specific to your reagent — viscosity, volume, dispensing method — and validate them through IQ/OQ/PQ. The key differentiator is that accuracy doesn't degrade as volume scales, because the validated process parameters are locked in.

Reagent stability starts with environment control. Our cleanrooms maintain precise temperature and humidity levels matched to your reagent's sensitivity requirements. Packaging processes are designed to minimize reagent exposure time outside controlled conditions. We support nitrogen blanketing, desiccant insertion, and moisture barrier packaging where required. Stability testing protocols can be integrated with your accelerated aging program.

Yes. Our diagnostics manufacturing capabilities cover the full range — from IVD consumables (reagent cartridges, blister packs, multi-well plates) to POC devices (lateral flow cassettes, microfluidic cartridges, rapid test kits). The manufacturing infrastructure is the same: precision dispensing, controlled-environment assembly, validated packaging. The process parameters are customized to each device type during development.

Transfer-to-manufacturing is where most diagnostics programs hit friction. LSO's approach starts with a DFM (design for manufacturability) review of your device — identifying issues with fill volumes, seal parameters, cartridge geometry, and material compatibility before they become production problems. We then develop and validate the manufacturing process through a structured pilot phase, scaling incrementally with full QC at each stage.

We provide the manufacturing-side documentation required for your submission — process validation reports, device history records, packaging validation data, and sterilization documentation. For IVD devices under FDA 510(k) or De Novo pathways, our documentation packages are formatted to support the manufacturing sections of your submission. We work alongside your regulatory team or consultant to ensure completeness.