MicroCoat
Contract Manufacturing

Reagent Manufacturing & Kit Production

From Individual Reagents to Finished Diagnostic Kits.

Microcoat provides flexible contract manufacturing for the IVD, biotechnology and life science industries. From buffer preparation and filling to lyophilization, kit assembly and final packaging, we deliver manufacturing solutions tailored to your product requirements.

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Reagent Manufacturing & Kit Production
  • Reagent Preparation
  • Lyophilization
  • Kit Assembly
Manufacturing expertise

Flexible Manufacturing. Reliable Products.

Successful diagnostic products depend on more than individual components. Consistent reagent preparation, controlled manufacturing and accurate kit assembly are essential for reliable product quality.

Microcoat combines technical expertise, established manufacturing processes and flexible production capabilities to support individual manufacturing steps or complete end-to-end solutions.

Benefits

End-to-End Capabilities

From reagent preparation and filling to kit assembly and final packaging.

Customized Manufacturing

Formulations, container formats and kit configurations tailored to your specifications.

Controlled Quality

Manufacturing under established quality management systems with documented processes and traceability.

Flexible Scale

Support for individual manufacturing steps as well as complete production runs.

Our manufacturing services

From Formulation to Final Packaging.

Explore our manufacturing capabilities for diagnostic reagents and complete kits — available as individual services or as part of an integrated production solution.

Buffer Preparation & Filling

We manufacture buffers, reagents and solutions according to your specifications, including controlled preparation and low bioburden filling.

  • Custom Formulation
  • Low Bioburden Filling
  • Batch Traceability

Lyophilization (Freeze-Drying)

Controlled freeze-drying processes help improve the stability and shelf life of sensitive reagents and biological materials.

  • Process Development
  • Controlled Parameters
  • Reproducible Quality

Kit Assembly & Packaging

We assemble customized IVD and life science kits, bringing together reagents, components, instructions for use, labeling and packaging according to your product requirements.

  • Reagent Dispensing
  • Component Assembly
  • Labeling & IFUs
  • Final Packaging

Customized Contract Manufacturing

Flexible manufacturing solutions supporting design transfer, scale-up and commercial production according to your specific requirements.

  • Design Transfer
  • Commercial Manufacturing
  • Scale-Up
  • Individual Production Steps
From components to complete kits

Every Component one Finished Product.

Reagent manufacturing and kit production bring multiple production steps together. Microcoat supports the preparation, filling, assembly and packaging of diagnostic products according to defined specifications.

  1. Reagents

    Buffers & solutions

  2. Containers

    Filled & labeled

  3. Kit Components

    IFU & additional parts

Kit assembly & packaging

Finished Diagnostic Kit

Configured, labeled and packaged according to customer requirements.

Quality & traceability

Controlled Processes. Traceable Production.

Quality and traceability are essential throughout diagnostic reagent and kit manufacturing. Microcoat operates under quality management systems in accordance with ISO 9001 and ISO 13485, with manufacturing processes supported by documentation, defined controls and traceability.

ISO 9001

Quality Management

ISO 13485

Medical Device Quality Management

Batch Documentation

Documented Manufacturing

Traceability

Trackable Production

Our process

From Your Specifications to Reliable Production.

1

Define Requirements

Clarify specifications, formulations, kit components, packaging requirements and expected manufacturing volumes.

2

Transfer & Establish

Transfer or establish manufacturing procedures, define process parameters and implement suitable documentation and controls.

3

Manufacture & Deliver

Manufacture reagents, assemble and package kits according to agreed specifications and supply requirements.

Knowledge Hub

Understand the Process

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Contract Manufacturing

GMP explained

The quality system that ensures every batch of a regulated product meets its specification.

5 min
Let's talk about your project

Let's Bring Your Reagents or Kits into Production.

Tell us about your reagent formulation, kit configuration or manufacturing requirements. Our team will review your inquiry and discuss suitable production solutions.

Contact

Tell Us About Your Project

Share a few details about your requirements. Our team will get in touch to discuss your project.

Service Needed

Multiple selections possible

Project Stage
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Complementary services

Still Developing Your Diagnostic Product?

Microcoat's Product Development Services support component selection, kit design, formulation and stability studies, helping prepare your diagnostic product for manufacturing.

Product Development

Looking for your partner?

From assay development to commercial manufacturing — we support your project at every stage.

Contact us