Shenandoah Biotechnology introduces expanded range of CTGrade recombinant proteins manufactured following cGMP practices

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.

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 <1043> 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.

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.

Erik Vaessen, Chief Business Officer, FUJIFILM Irvine Scientific

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.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    FUJIFILM Irvine Scientific. (2022, December 07). Shenandoah Biotechnology introduces expanded range of CTGrade recombinant proteins manufactured following cGMP practices. News-Medical. Retrieved on October 12, 2024 from https://www.news-medical.net/news/20221207/Shenandoah-Biotechnology-introduces-expanded-range-of-CTGrade-recombinant-proteins-manufactured-following-cGMP-practices.aspx.

  • MLA

    FUJIFILM Irvine Scientific. "Shenandoah Biotechnology introduces expanded range of CTGrade recombinant proteins manufactured following cGMP practices". News-Medical. 12 October 2024. <https://www.news-medical.net/news/20221207/Shenandoah-Biotechnology-introduces-expanded-range-of-CTGrade-recombinant-proteins-manufactured-following-cGMP-practices.aspx>.

  • Chicago

    FUJIFILM Irvine Scientific. "Shenandoah Biotechnology introduces expanded range of CTGrade recombinant proteins manufactured following cGMP practices". News-Medical. https://www.news-medical.net/news/20221207/Shenandoah-Biotechnology-introduces-expanded-range-of-CTGrade-recombinant-proteins-manufactured-following-cGMP-practices.aspx. (accessed October 12, 2024).

  • Harvard

    FUJIFILM Irvine Scientific. 2022. Shenandoah Biotechnology introduces expanded range of CTGrade recombinant proteins manufactured following cGMP practices. News-Medical, viewed 12 October 2024, https://www.news-medical.net/news/20221207/Shenandoah-Biotechnology-introduces-expanded-range-of-CTGrade-recombinant-proteins-manufactured-following-cGMP-practices.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
FUJIFILM Irvine Scientific Expands BalanCD CHO Media Platform Portfolio for Bioprocessing