Product development

Custom product realization

Microcoat possesses unique expertise not only in the development of diagnostic assays but also the infrastructure to develop and manufacture market-ready products. We consult a broad expert network and contractors to individually meet the requirements for your product. We guide you in the benchmarking and selection of the optimal methodology, test format and components. In cooperation with our manufacturing division, we offer the production of prototype kits, pilot lots and full scale production lots.

Our Expertise

Microcoat possesses unique expertise not only in the development of diagnostic assays but also the infrastructure to develop and manufacture market-ready products.

According to our customer´s requirements, we perform

Sourcing of suppliers and supplier qualification

Benchmarking of components and reagents

Design of kit layout (inlays, bottles, labels, boxes, etc.)

Development of freeze-drying protocols

Stability studies of components and kits (shipping procedure, long-time and accelerated storage)

Services

Consulting in regulatory aspects (e.g. IVD)

Production of prototypes and pilot lots (in our manufacturing department)

Technical documentation

Validation and stability studies

Have a look:

Series production of diagnostic kits

Components supply, lyophilozation, filling and packaging

Series production of diagnostic kits

Components supply, lyophilozation, filling and packaging

protein production

Fermentation up to 30 L and downstream processing of proteins and antigens

protein production

Fermentation up to 30l and downstream processing of proteins and antigens

Certified quality

Development and production according to ISO 9001 and EN ISO 13485.

Certified quality

Development and production according to EN ISO 9001 and EN ISO 13485.