Diagnostic Assay Scale-Up and Manufacturing

Full-scale cGMP and ISO 13485 compliant manufacturing services for in vitro diagnostic products. Supports formulation, fill, finish, and distribution from concept to commercial scale.

Full-scale manufacturing services for diagnostic assays, tests, and related medical products. Provides scalable production capacity from development through commercial supply.

Fully automated high-volume production infrastructure for diagnostic consumables meeting commercial and regulatory requirements. Enables scaling from pilot batches to large-scale manufacturing.

Full manufacturing services for diagnostic devices including production control, validation, and quality assurance under ISO13485 standards.

Manufacturing transfer services from prototype to scalable serial production for diagnostic devices. Includes production process definition, test means development, and quality system implementation. Ensures smooth transition to commercial manufacturing while maintaining regulatory compliance.

Scalable manufacturing services for complex medical devices with regulatory compliance and quality assurance. Supports production from prototype to full commercial scale.

Contract manufacturing and CDMO services for diagnostic and medical devices with full regulatory compliance. Offers scalable production capabilities with German precision manufacturing standards. Supports complete product lifecycle from prototype development through commercial production.

Contract manufacturing operations for diagnostic products and components under Good Manufacturing Practice standards. Includes process validation, quality assurance, and full regulatory compliance documentation.

Contract manufacturing of immunoassays for in vitro diagnostic applications. Provides scalable production capacity and expertise to global IVD companies.

Contract manufacturing services for in vitro diagnostic reagents and testing products. These services support development and production of diagnostic solutions for clinical use.

In-house medical device manufacturing facility for chemical production and quality assurance. Supports diagnostic manufacturing with consistent quality and reliable supply.

Full-service contract manufacturing organization providing production, quality control, and packaging for lateral flow and ELISA-based immunoassays at clinical and commercial scales.