New sizes of R&D-grade DENARASE® available

New sizes of R&D-grade DENARASE® available

c-LEcta has just launched additional sizes of DENARASE® for research and development use. Being widely applied in biopharmaceutical R&D and manufacturing, DENARASE® sizes of 1 MU and 5 MU will now also be available as R&D-grade, in addition to GMP-grade.

The additional sizes of the R&D-grade will be named “DENARASE® 1000 kU” and “DENARASE® 5000 kU”. They are well suited for R&D stages, where convenient and cost-efficient access to raw materials is key. R&D-grade DENARASE is produced in conformity with ISO 9001 standard, with shipment and storage under less strict regulatory requirements. In the near future, this allows us to work with additional local distributors and warehouses thereby ensuring fast and convenient delivery to customers.

From a technical performance perspective, DENARASE R&D-grade is equal to the GMP-grade and the parameters on the specification are the same. In summary, the combination of both quality grades allows for a seamless transition from early process development towards biopharmaceutical manufacturing under GMP.

DENARASE® endonuclease is already well established in the biopharma industry. It is applied for the degradation of undesired DNA and RNA during the manufacturing of biopharmaceutical products like viral vectors. In 2022, DENARASE was delivered to more than 220 customers in 23 countries.

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