Shenandoah Biotechnology Introduces Expanded Range of CTGrade Recombinant Proteins Manufactured Following cGMP Practices
06 Dec 2022
AcquisitionGene Therapy
WARMINSTER, Penn.--(BUSINESS WIRE)--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 factors 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 function for new cell and gene therapies applications.
'The predictability and performance of CTGrade recombinant proteins help cell and gene therapy developers accelerate delivery of life-changing therapies to market. The biological activity of these 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.'
Cytokines and growth factors are signaling molecules that regulate cell growth, differentiation, and motility, as well as immune and inflammatory responses, and are therefore 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 optimal to minimize variability and ensure predictable workflow performance. Designed to support basic, translational, and clinical research, as well as commercial applications, the CTGrade products are produced from E. coli and are manufactured in a facility that does not 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 for ancillary materials has been considered in the manufacture of these products.
The Shenandoah products are developed harnessing FUJIFILM Irvine Scientific’s extensive regulatory expertise and quality control to ensure lot-to-lot consistency, reproducibility in downstream cell culture processes, and the smooth transition of biological therapies from preclinical to clinical phases.
Erik Vaessen, chief business officer, FUJIFILM Irvine Scientific, said: “The predictability and performance of CTGrade recombinant proteins help cell and gene therapy developers accelerate delivery of life-changing therapies to market. The biological activity of these 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.” He added: “The availability 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 year.”
All products are available from Shenandoah Biotechnology and FUJIFILM Irvine Scientific in multiple package sizes of 50 µg, 100 µg, and 1 mg, as well as with custom sizing and packaging. To view the entire range of Shenandoah Biotechnology recombinant proteins that support early research to further manufacturing visit http://www.shenandoah-bt.com.
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