Shenandoah CTGrade Recombinant Proteins

Shenandoah CTGrade Recombinant Proteins

Shenandoah’s state of the art 15,000-ft² cGMP production facility was purpose-built to support the production scientists, QC team, and CTGrade recombinant protein products from the outset.  The facility enables Shenandoah to scale production batches while complying to appropriate sections of 21 CFR parts 210, 211, and 820 FDA regulations. Shenandoah’s cGMP production facility guarantees our products are made under the most stringent guidelines to ensure our customers have the highest quality products and a secure supply chain for critical raw materials.

Shenandoah CTGrade recombinant proteins are manufactured to the highest quality standard within the industry.  Rigorous quality control procedures ensure lot-to-lot consistency providing reproducibility in downstream cell culture processes.  In addition, CTGrade rh IL-2 is standardized to the WHO International Reference standard, allowing direct activity comparison to clinically available formulations of rh IL-2.  The release of CTGrade recombinant proteins will enhance the development of cell-based therapies within the biopharmaceutical industry.

Planned Product Release Dates

All Products are Beta Lactam Free and contain no animal-derived materials.

Containing no animal-derived materials, CTGrade recombinant proteins are produced in E. coli and other sources, are Beta Lactam-free, and are manufactured by Shenandoah Biotechnology, Inc. in an ISO 9001:2015 certified facility that follows cGMP guidelines.