GMP Proteins
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.
Develop your Cell Therapy Manufacturing Process with Confidence using R&D Systems GMP Cytokines and Growth Factors
Years of Protein Manufacturing Expertise
Leveraging years of expertise in protein development, manufacturing, quality control, and regulatory support, we offer industry-leading GMP proteins for ancillary use.
Seamless Transition From Preclinical to GMP
We ensure a seamless transition to GMP by using the same clone, sequence, and expression system as our RUO and animal-free grade materials.
Reliable Supplier
As cellular therapies advance, the demand for high-quality raw materials like GMP cytokines and growth factors grows. Our large, consistent, safe, and traceable supply of GMP proteins supports cell therapy.
Compliance Documentation
Recognizing customers’ regulatory filing end goals, many of our GMP proteins are supported by drug master files, facilitating your IND's swift approval. Certificates of Analysis are available for released lots.
Dedicated Custom Team
Sometimes cell therapies need tailor-made protein options. For custom GMP proteins or formulations, our dedicated team will work with you to provide personalized fill options.
Cytokines & Growth Factors
for Regenerative Medicine
Protein |
Animal-Free RUO |
GMP |
GMP Source |
|
Activin A |
|
DMF on file |
CHO |
|
Betacellulin |
DMF on file |
E.coli |
|
|
BDNF |
DMF on file |
E.coli |
|
|
BMP-2 |
|
CHO |
|
|
BMP-4 |
E.coli |
||
|
EGF |
DMF on file |
E.coli |
|
|
FGF basic/FGF2 |
E.coli |
||
|
FGF basic/FGF2 Heat Stable |
DMF on file |
E.coli |
|
|
Flt-3 Ligand/FLT3L |
DMF on file |
E.coli |
|
|
GDF-8/Myostatin |
|
NS0 |
|
|
GDNF |
|
NS0 |
|
|
GM-CSF |
DMF on file |
E.coli |
|
|
HGF |
|
NS0 |
|
|
IGF-I |
DMF on file |
E.coli |
|
|
KGF/FGF-7 |
E.coli |
||
|
LR3 IGF-I |
|
E.coli |
|
|
M-CSF |
E.coli |
||
|
Noggin |
|
NS0 |
|
|
PDGF-AA |
E.coli |
||
|
PDGF-BB |
E.coli |
||
|
SCF/c-kit Ligand |
DMF on file |
E.coli |
|
|
Sonic Hedgehog/Shh |
E.coli |
||
|
TGF-beta 1 |
|
DMF on file |
CHO |
|
Thrombopoietin |
E.coli |
||
|
VEGF |
DMF on file |
E.coli |
|
|
Wnt-3a |
|
CHO |
Cytokines for Immune Cell Therapy
Protein |
Animal-Free RUO |
GMP |
Specialised Formats |
GMP Source |
|
IFN-gamma |
DMF on file |
|
E.coli |
|
|
IL-1 beta |
DMF on file |
|
E.coli |
|
|
IL-2 |
DMF on file |
E.coli |
||
|
IL-3 |
|
E.coli |
||
|
IL-4 |
DMF on file |
|
E.coli |
|
|
IL-6 |
DMF on file |
|
E.coli |
|
|
IL-7 |
DMF on file |
E.coli |
||
|
IL-10 |
DMF on file |
|
E.coli |
|
|
IL-15 |
DMF on file |
E.coli |
||
|
IL-18 |
|
E.coli |
||
|
IL-21 |
DMF on file |
E.coli |
||
|
TNF-alpha |
DMF on file |
|
E.coli |
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.
Not only are the proteins consistent lot-to-lot, but also across RUO, animal-free, 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-grade cytokines and growth factors are produced under regulatory guidelines for ancillary materials in cell therapy manufacturing processes. This includes extensive quality control testing and comprehensive documentation of manufacturing systems and traceability of source materials. You can be confident you will receive a consistent, safe, and traceable supply of raw materials. We perform regular audits of our facilities and welcome customer audits.