Material Grades to fit your Development Stage
Prototype-grade
Prototype-grade reagents enable creation of early access product samples with representative manufacturing to test concepts, designs, and functionality. Prototype-grade material is supported by a certificate of analysis, a safety data sheet, and user manuals. The prototype stage allows us to work with partners and customers to evaluate compatibility and optimize performance before moving to larger-scale production.
Research-grade
Research-grade products offer enhanced reliability and quality and include raw-material traceability and animal-origin–free production under an ISO 9001 certified quality management system. These reagents are suitable for preclinical work, optimization, and process development.
Building Manufacturing Capabilities, Ensuring Safety
With support from Donaldson, Isolere Bio is developing both internal and outsourced manufacturing capabilities for all IsoTag reagents to offer dual product sourcing and thus mitigate supply chain risk. We have planned strategic development of different reagent grades, each serving a unique purpose in the therapeutic development and production life cycle:
Manufacturing-grade
Manufacturing-grade materials are identical to research-grade reagents but produced with validated processes and include regulatory support files (RSFs), validation reports, and full design history files. To support customers using these products, a drug master file (DMF) will be submitted to the US Food and Drug Administration outlining the manufacturing, processing, packaging, and storage of IsoTag reagents. Through the DMF, we share critical technical data with regulators and partners while protecting proprietary information to support compliance with safety and quality standards.