Life Science Insights & Case Studies | Life Science Group (LSG)

Case Study: ProtonDx x LSG

Written by Life Science Group | Nov 13, 2026, 2:47:34 PM

From Research and Development to Commercial Scale: Diagnostic Kit Manufacturing and Fulfilment for ProtonDx

Introduction

ProtonDx, a spinout from Imperial College London, develops rapid, portable diagnostic platforms designed to improve access to testing in both human and animal health.

As ProtonDx expanded the use of its technology across multiple markets, it needed a manufacturing and fulfilment partner for its diagnostic kits: one that could support product rollout without pulling internal scientific and commercial teams away from innovation and customer development. Life Science Group (LSG) became that partner.

The Challenge: Scaling Up Once Products Start Selling at Volume

ProtonDx carries out its own research and development. Kit preparation at R&D scale works well in-house, but once a product becomes commercial and starts selling at volume, the picture changes. ProtonDx did not have the space or the capability to prepare kits at large scale.

Producing, labelling, dispensing, assembling, storing and shipping kits internally would have put increasing pressure on a team whose strengths are innovation and customer development. At the same time, customer opportunities in diagnostics can emerge quickly, often needing validation batches or pilot quantities at short notice.

ProtonDx needed a scale-up partner: one that could take each product from the research environment into consistent, quality-managed manufacture, and then handle everything that follows.

Life Science Group's Role

From research environment to quality-aligned manufacture

When a ProtonDx product reaches the commercial stage, LSG transfers kit preparation from ProtonDx's research environment into LSG's quality-aligned manufacturing environment. Manufacturing under LSG's GMP-aligned processes and ISO 9001 and ISO 13485 certified quality systems gives ProtonDx consistent, high-quality kits at commercial volumes. Manufacturing responsibilities include:

  • dispensing liquids into customer-specified tube formats
  • producing and assembling complete branded diagnostic kits
  • managing product-specific labelling
  • quality-controlled manufacturing and packaging

Taking the whole supply chain off ProtonDx's hands

LSG's role goes beyond manufacture. LSG stores finished kits and dispatches them directly to ProtonDx's customers, managing logistics and fulfilment on ProtonDx's behalf. This includes:

  • stock management and inventory support
  • storing finished products ready for distribution
  • dispatch, logistics and fulfilment direct to ProtonDx customers

With manufacture, storage and fulfilment in one place, ProtonDx has a single, fully outsourced operational solution. Production schedules can also be adjusted as new opportunities arise, supporting customer evaluations, validation programmes and pilot projects without ProtonDx investing in manufacturing capacity of its own.

Key Outcomes and Achievements

  • A clear route from R&D to commercial supply, with kits moving into quality-aligned manufacture as they start selling at volume.
  • Consistent, high-quality kit manufacture at commercial scale, without ProtonDx needing extra space, equipment or staff.
  • An end-to-end, outsourced supply chain covering manufacture, storage, logistics and fulfilment.
  • Faster response to new commercial and validation opportunities.
  • A strong, ongoing partnership: ProtonDx keeps LSG informed of progress and sees LSG as its scale-up partner.

The result is that ProtonDx can stay focused on research, development and commercialising its diagnostic platform, while LSG manages the operational complexity behind the scenes.

Summary: LSG Products and Solutions

The ProtonDx partnership shows how LSG supports diagnostics companies as products move from development into commercial deployment, acting as a scale-up partner rather than simply a supplier. Relevant capabilities include:

  • Transfer from R&D into quality-aligned, GMP-aligned manufacture
  • Custom liquid manufacture and dispensing
  • Diagnostic kit assembly, packaging and labelling
  • Inventory management and stock holding
  • Dispatch, logistics and direct-to-customer fulfilment
  • Responsive production scheduling for pilot studies, validation programmes and commercial rollouts

Ready to scale a diagnostic product beyond the lab? Find out more about LSG custom manufacturing, send us a custom liquid enquiry, or email salesdist@lifesciencegroup.co.uk.

Frequently Asked Questions

When should a diagnostics company outsource kit manufacturing?

Often at the point a product becomes commercial and starts selling at volume. R&D-scale kit preparation can be done in-house, but consistent manufacture at scale needs space, capacity and a quality-managed environment that many growing companies do not have.

What does scaling up diagnostic kit manufacturing involve?

Transferring kit preparation from a research setting into a quality-aligned manufacturing environment, with defined processes for dispensing, assembly, labelling and packaging, so every kit is made consistently at higher volumes.

What is diagnostic kit assembly?

Diagnostic kit assembly brings together all of a test's components – reagents, tubes, consumables, labels and instructions – into finished, branded kits ready for the end user.

Can LSG store kits and ship them to our customers?

Yes. LSG can store finished kits and dispatch them directly to your customers, managing stock, logistics and fulfilment on your behalf.

Can LSG produce small validation or pilot batches?

Yes. LSG adjusts production schedules to supply validation batches and pilot quantities for customer evaluations, as well as larger volumes for commercial rollout.