Shenandoah Biotechnology Inc., a FUJIFILM Irvine Scientific company and leading manufacturer of recombinant proteins, today announced it has expanded its CTGrade portfolio of cytokines and growth aspects for cell and gene therapies manufactured following cGMP guidelines. The expanded range, which is now available directly through FUJIFILM Irvine Scientific, includes CTGrade cytokines IL-2, IL-3, IL-6, IL-7, IL-10, IL-15, IL-21, and FLT-3 ligand, with additional proteins in development that optimize cell proliferation and performance for brand spanking new cell and gene therapies applications.

Cytokines and growth aspects are signaling molecules that regulate cell growth, differentiation, and motility, in addition to immune and inflammatory responses, and are subsequently used for the expansion, differentiation, and maintenance of cells in most cell therapies. As manufacturers move towards clinical trials, using raw materials manufactured following cGMP guidelines is perfect to attenuate variability and ensure predictable workflow performance. Designed to support basic, translational, and clinical research, in addition to business applications, the CTGrade products are produced from E. coli and are manufactured in a facility that doesn’t use or process beta-lactam containing materials. No animal- or human-derived materials were used during manufacturing or as ingredients. These products are manufactured, tested, and released in an ISO 9001:2015 certified facility following cGMP practices. USP chapter <1043> for ancillary materials has been considered within the manufacture of those products.

The Shenandoah products are developed harnessing FUJIFILM Irvine Scientific’s extensive regulatory expertise and quality control to make sure lot-to-lot consistency, reproducibility in downstream cell culture processes, and the sleek transition of biological therapies from preclinical to clinical phases.

The predictability and performance of CTGrade recombinant proteins help cell and gene therapy developers speed up delivery of life-changing therapies to market. The biological activity of those high-performing proteins adheres to WHO International standards, where applicable, providing consistent, lot-to-lot biological activity and performance, and ultimately successful progression to the clinic.”

Erik Vaessen, Chief Business Officer, FUJIFILM Irvine Scientific

He added: “The supply of this expanded range directly through FUJIFILM Irvine Scientific provides our customers worldwide with a single point of access for cGMP cell culture solutions, following our acquisition of Shenandoah Biotechnology in March this yr.”

All products can be found from Shenandoah Biotechnology and FUJIFILM Irvine Scientific in multiple package sizes of fifty µg, 100 µg, and 1 mg, in addition to with custom sizing and packaging. To view the complete range of Shenandoah Biotechnology recombinant proteins that support early research to further manufacturing visit http://www.shenandoah-bt.com.

Source:

Fujifilm Irvine Scientific