Material Grades to fit your Development Stage
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:
Validated ELISA Kits for Testing Residual IsoTag™ Values
Available through Cygnus Technologies, these assays provide sensitivity to residual IsoTag™ reagent to less than 1ng/mL using a polyclonal two-site immune-enzymatic method. The kits can be used as a tool to aid in optimizing your therapeutic’s purification process development and in routine quality control of in-process manufacturing as well as final product. The assays have been fully qualified by FDA and ICH guidelines, including precision studies, spike-recovery, dilutional linearity, interference, and cross reactivity analysis. This qualification will supplement, but not replace, end-user qualification and validation specific to individual drug substances. The product is manufactured in ISO 9001 certified facility and qualification summary, CoA, and SDS are available upon request.
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 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.
Research-grade
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.
