CTG GMP Products

CTG GMP Recombinant Proteins and Growth Factors

Shenandoah’s state of the art 15,000-ft² cGMP production facility was purpose-built to support the production scientists, QC team, and CTG™ 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.

With the first of a series of launches, Shenandoah Biotechnology’s Recombinant Human IL-2_C126S CTG™ is 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, CTG™ hIL-2_C126S is standardized to the WHO International Reference standard () allowing direct activity comparison to clinically available formulations of recombinant hIL-2.  The release of CTG™ hIL-2 ( catalog number CTG™-500-01) and future releases in the CTG™ product line from Shenandoah Biotechnology will enhance the development of cell-based therapies within the biopharmaceutical industry.

Planned Product Release Dates 

All Products are Animal Free and Beta Lactam Free

For research use or further manufacturing and in ex vivo cell therapy applications. Shenandoah’s CTG™ GMP grade recombinant proteins are not for Human use in direct in vivo applications or for direct clinical use as a drug, therapeutic, biologic or medical devices.