GMP Proteins for Cell Therapy Manufacturing

GMP Quality Compliance

Develop your cell therapy manufacturing process with confidence by using R&D Systems™ GMP cytokines and growth factors. Our years of expertise in protein development and manufacturing, stringent quality control, and regulatory support allow us to offer industry-leading GMP proteins for ancillary use. We often use the same clone, sequence, and expression system as our RUO and animal-free grade materials to make your switch to GMP as seamless as possible.

Request a GMP Protein Sample

Cytokines for Immune Cell Therapy

Protein	Animal-Free RUO	GMP	Specialized Formats	GMP Source
IFN-gamma	AFL285	285-GMP DMF on file		E.coli
IL-1 beta	AFL201	201-GMP		E.coli
IL-2	BT-002-AFL	BT-002-GMP DMF on file	Liquid	E.coli
IL-3	AFL203	203-GMP		E.coli
IL-4	BT-004-AFL	BT-004-GMP DMF on file		E.coli
IL-6	AFL206	206-GMP DMF on file		E.coli
IL-7	BT-007-AFL	BT-007-GMP DMF on file	Liquid Process-Sized Vials ProPak™ Closed-System	E.coli
IL-10		1064-GMP DMF on file		E.coli
IL-15	BT-015-AFL	BT-015-GMP DMF on file	Liquid Process-Sized Vials ProPak Closed-System	E.coli
IL-18		Coming Soon		E.coli
IL-21	BT-021-AFL	BT-021-GMP	Liquid	E.coli
TNF-alpha	AFL210	210-GMP		E.coli

Cytokines & Growth Factors for Regenerative Medicine

Protein	Animal-Free RUO	GMP	GMP Source
Activin A		338-GMP DMF on file	CHO
Betacellulin	BT-BTC-AFL	BT-BTC-GMP DMF on file	E.coli
BDNF	BT-BDNF-AFL	BT-BDNF-GMP DMF on file	E.coli
BMP-2		355-GMP	CHO
BMP-4	AFL314E	314E-GMP	E.coli
EGF	AFL236	236-GMP DMF on file	E.coli
FGF basic/FGF2	BT-FGFB-AFL	BT-FGFB-GMP DMF on file	E.coli
FGF basic/FGF2 Heat Stable	BT-FGFBHS-AFL	BT-FGFBHS-GMP	E.coli
FGF7		Coming Soon
Flt-3 Ligand/FLT3L	BT-FT3L-AFL	BT-FT3L-GMP DMF on file	E.coli
GDF-8/Myostatin		788-GMP	NS0
GDNF		212-GMP	NS0
GM-CSF	AFL215	215-GMP	E.coli
HGF		294-GMP	NS0
IGF-I	AFL291	291-GMP DMF on file	E.coli
KGF/FGF-7		251-GMP	E.coli
LR3 IGF-I		8335D-GMP	E.coli
M-CSF	AFL216	216-GMP	E.coli
Noggin Fc tag		3344-GMP	NS0
PDGF-AA	AFL221	221-GMP	E.coli
PDGF-BB	AFL220	220-GMP	E.coli
SCF/c-kit Ligand	BT-SCF-AFL	BT-SCF-GMP DMF on file	E.coli
Sonic Hedgehog (C24II) N-Terminus	AFL1845	1845-GMP	E.coli
Sonic Hedgehog N-Terminus		1314-GMP	E.coli
TGF-beta 1		240-GMP DMF on file	CHO
Thrombopoietin		288E-GMP DMF on file	E.coli
VEGF	BT-VEGF-AFL	BT-VEGF-GMP DMF on file	E.coli
Vitronectin		Coming Soon
Wnt-3a		5036-GMP	CHO

For Closed-Process Cell Therapy Manufacturing: ProPak GMP Cytokines

GMP IL-7 and IL-15 are now available in single-use weldable bags. These 1 L process-sized protein bags reduce both variability and risk for your cell therapy, plus eliminate reconstitution and aliquoting.

Learn More About Closed-Process Solutions

View GMP IL-2 Consistency Data

Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-2

(A) Three independent lots of GMP-grade Recombinant Human IL-2 (R&D Systems, Catalog # BT-002-GMP) were tested for their ability to stimulate proliferation of CTLL-2 mouse cytotoxic T cells. The ED₅₀ for this effect is 0.03-0.25 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-2 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (B, C) The purity of the three independent lots of GMP-grade Recombinant Human IL-2 shown in part A were assessed by CE-SDS on Maurice (ProteinSimple, Catalog # 090-000) under reducing (R; part B) and non-reducing (NR; part C) conditions and visualized in Compass for iCE software. The gel views obtained from the Compass software are shown.

View GMP IL-7 Consistency Data

Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-7

(A) Three independent lots of GMP-grade Recombinant Human IL-7 (R&D Systems, Catalog # BT-007-GMP) were tested for their ability to stimulate proliferation of PHA-activated human peripheral blood lymphocytes. The ED₅₀ for this effect is 0.1-0.5 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-7 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (B, C) The purity of the three independent lots of GMP-grade Recombinant Human IL-7 shown in part A were assessed by CE-SDS on Maurice (ProteinSimple, Catalog # 090-000) under reducing (R; part B) and non-reducing (NR; part C) conditions and visualized in Compass for iCE software. The gel views obtained from the Compass software are shown. The IS band is a 10 kDa Maurice CE-SDS Internal Standard Marker (ProteinSimple, Catalog # 046-144) that was added to each sample to calculate the relative migration time (RMT).

View GMP IL-10 Consistency Data

Activity, lot-to-lot consistency, and purity testing of R&D Systems GMP IL-10 protein

(A) Three independent lots of GMP-grade Recombinant Human IL-10 (R&D Systems, Catalog # 1064-GMP) were tested for their ability to stimulate proliferation of MC/9-2 mouse mast cells. The ED₅₀ for this effect is 0.0750-0.750 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-10 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (B, C) The purity of the three independent lots of GMP-grade Recombinant Human IL-10 shown in part A were assessed by CE-SDS on Maurice (ProteinSimple, Catalog # 090-000) under reducing (R; part B) and non-reducing (NR; part C) conditions and visualized in Compass for iCE software. The gel views obtained from the Compass software are shown. The IS band is a 10 kDa Maurice CE-SDS Internal Standard Marker (ProteinSimple, Catalog # 046-144) that was added to each sample to calculate the relative migration time (RMT).

Animal-Free GMP Proteins for Cell Therapy Manufacturing

Animal-free RUO and GMP recombinant human proteins are manufactured using equipment and reagents that are certified animal-free. Our dedicated controlled-access animal-free laboratories ensure that at no point in production are these products exposed to potential contamination by animal components or byproducts.

Transition Seamlessly from RUO to GMP

Both AF 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.

Supply Chain Continuity

It is critical to secure a stable supply of GMP-grade proteins for use as raw materials in ex vivo cell manufacturing. This becomes progressively more important during the transition from early- to late-stage clinical trials. We have the expertise and ability to scale up your GMP protein supply. Working with your process forecasting, we will provide supply and quality agreements to ensure the consistent supply of the GMP proteins you require.

Risk mitigation management
Secondary cell banking facility
Quality-controlled change and notification process

We produce GMP-grade cytokines and growth factors 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 we welcome customer audits.

Visit GMP Capabilities for an overview of our GMP facility certifications world wide.

Regulatory Certifications and Guidelines for Our GMP Manufacturing Facility

ISO 9001:2015, ISO 13485:2016-certified facilities including a completely animal-free facility dedicated to manufacturing GMP proteins
USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products

Documentation and Traceability for GMP Protein Production

We work with preferred vendors for raw materials to mitigate risk and adhere to a strict definition of animal-free conditions. Certificates of Origin (COOs) are available upon request.

Individual specification sheets with all testing results, reviewed by both our Quality Control (QC) and Quality Assurance (QA) departments
Lot-specific Certificates of Analysis
Full QA review of all batch and bottling records before any material is shipped
Documented processes and QA control of documentation and process changes
Personnel training programs
Raw material testing, tracing, and vendor qualification/monitoring
Fully validated equipment, processes, and test methods
Equipment calibration schedules using a computerized calibration program
Facility maintenance and safety programs
Material review board for variances
Stability monitoring over the shelf life of each product
Product change notifications

Safety and Quality Control Testing for GMP Quality Management Systems

We pay strict attention to detail at all levels of the protein manufacturing process. Our quality management systems for GMP proteins include detailed Standard Operating Procedures (SOPs) and quality-controlled documentation of the manufacturing equipment and procedures. You can rely on our GMP proteins for building a consistent and robust cell therapy manufacturing program.

Biological potency specification
Defined purity specifications
Stability testing program
Defined endotoxin specifications
Host cell protein content testing
Sterility testing according to USP
Additional testing available depending on your needs

GMP Protein Certificate of Analysis Specifications

We provide each manufactured lot of GMP protein with a Certificate of Analysis (CofA) that documents the relevant quality systems and product specifications. Prior to CofA release, we perform a full QA review of all batch and bottling records. Here is what you can expect to find on our CofAs:

Actual vial fill (protein mass) for accurate reconstitution
Source information
N-terminal sequencing of the first 10 amino acids
Purity specification
Bioactivity assay including benchmarking against a master lot
Sterility testing to USP
Endotoxin levels
Host cell protein specification
Host cell DNA specification
Stability statement
Certifications and regulatory guidelines followed

Additional Resources

Literature

Key Considerations for Cytokine Supplier Selection for Cell Therapies Article

GMP Cytokines and Growth Factors for Therapeutic Manufacturing Brochure

Website Resources

Liquid Cytokines

Recombinant Proteins

GMP Capabilities

T Cell Manufacturing for Cell Therapy

Natural Killer (NK) Cells for Cell Therapy

Induced Pluripotent Stem Cells (iPSCs)

Cell and Gene Therapy

Bioprocessing: Cell Culture Development

Custom Protein Services

Custom Services for Cell and Gene Therapy

State-of-the-Art GMP Protein Manufacturing Facility

We're committed to meeting the increasing demands of therapeutic cell manufacturing. Our facility supports large-scale production of GMP-grade, E. coli-derived recombinant proteins.