GMP Proteins For Cell Therapy Manufacturing

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Develop Your Cell Therapy Manufacturing Process With Confidence

Using R&D Systems GMP Cytokines and Growth Factors

Highly consistent GMP proteins are key ancillary reagents for building your cell manufacturing program. We follow all relevant regulatory guidelines to ensure a consistent, safe, and traceable supply of animal-free bioactive proteins.

Available GMP Proteins

ǂ DMF is on file

Lot-to-Lot Consistency

As you scale your clinical manufacturing process, it often becomes necessary to use GMP cytokines and growth factors from different lots. Through decades of manufacturing expertise, R&D Systems had developed a mature quality management system with detailed protocols, creating recombinant proteins with industry-leading consistency. Each new lot is tested against a master lot and must pass stringent quality control specifications for activity in a well-defined bioassay.

Three independent lots of GMP IL-2 (A, Catalog # BT-002-GMP), IL-7 (B, Catalog # BT-007-GMP), and IL-10 (C, Catalog # 1064-GMP) were tested for their ability to stimulate proliferation of CTLL-2 mouse cytotoxic T cells, PHA-activated human peripheral blood lymphocytes, and MC/9-2 mast cells, respectively. Each trace on the graphs represents data obtained from a different manufacturing run, demonstrating the lot-to-lot consistency of each protein.

Grade-to-Grade Consistency

Not only are the proteins consistent lot-to-lot, but also across RUO, animal-free RUO, and GMP grades. Both animal-free RUO and GMP grades of E. coli sourced proteins share the same sequence, source, formulation, activity and purity specifications, manufacturing site and personnel, and vial type – ensuring equivalent performance and process continuity as you transition to the clinic.
 

The three grades of IL-2 (A, Catalog # BT-002, BT-002-AFL, and BT-002-GMP), IL-4 (B, Catalog # BT-004, BT-004-AFL, and BT-004-GMP), and BDNF (C, Catalog # BT-BDNF, BT-BDNF-AFL, and BT-BDNF-GMP) were tested for their ability to stimulate proliferation of CTLL-2 mouse cytotoxic T cells, TF-1 human erythroleukemic cells, and BaF mouse pro-B cells transfected with TrkB, respectively. All grades show equivalent bioactivity, enabling a seamless transition as higher levels of regulation and documentation are needed.

GMP Quality Policy and Regulatory Support

GMP-grade proteins are produced under regulatory guidelines for ancillary materials in cell therapy manufacturing processes. From quality control to comprehensive documentation, you can be confident you will receive a consistent, safe, and traceable supply of raw materials. 

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