GMP Proteins for Cell Therapy Manufacturing

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 research grade materials to make your switch to GMP as seamless as possible.

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Bio-Techne's GMP Manufacturing Facilities - Invested In the Next Generation of Therapeutics

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.

Entire facility dedicated to manufacturing GMP proteins
Completely animal-free – No animal components are allowed in the facility
Capacity – 61,000 sq. ft. to meet your current and future supply requirements
Expandability – Available space to build additional capacity
ISO 5/7/8 cleanrooms for the entire production process

Learn More About Our New Facility

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The use of high quality growth factors and cytokines is paramount to ensuring safety, bioactivity, and minimal batch-to-batch variability. We ensure lot-to-lot consistency in both purity and bioactivity with our robust quality management system. Greater cytokine and growth factor potency also lowers the amount of protein needed and helps to reduce manufacturing costs.

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).

GMP Protein (Human)	Source	Preclinical Animal-Free Protein
Activin A ‡	CHO
Betacellulin ‡	E.coli	BT-BTC-AFL
BMP-2	CHO
BMP-4	E.coli	AFL314E
EGF ‡	E.coli	AFL236
FGF basic/FGF2	E.coli	BT-FGFB-AFL
Flt-3 Ligand/FLT3L	E.coli	BT-FT3L-AFL
GDF-8/Myostatin	NS0
GDNF	NS0
GM-CSF	E.coli	AFL215
HGF	NS0
IFN-gamma ‡	E.coli	AFL285
IGF-I ‡	E.coli	AFL291
IL-1 beta	E.coli	AFL201
IL-10	E.coli
IL-15 * ‡ #	E.coli	BT-015-AFL
IL-2 * ‡ #	E.coli	BT-002-AFL
IL-21 ‡	E.coli	AFL8879
IL-3	E.coli	AFL203
IL-4 ‡	E.coli	BT-004-AFL
IL-6 ‡	E.coli	AFL206
IL-7 * ‡ #	E.coli	BT-007-AFL
KGF/FGF-7	E.coli
LR3 IGF-I	E.coli
M-CSF	E.coli	AFL216
Noggin Fc tag	NS0
PDGF-AA	E.coli	AFL221
PDGF-BB	E.coli	AFL220
SCF/c-kit Ligand ‡	E.coli	BT-SCF-AFL
Sonic Hedgehog (C24II) N-Terminus	E.coli	AFL1845
Sonic Hedgehog N-Terminus	E.coli
TGF-beta 1 ‡	CHO
Thrombopoietin ‡	E.coli
TNF-alpha	E.coli	AFL210
VEGF ‡	E.coli	BT-VEGF-AFL
Wnt-3a	CHO

‡ DMF on file.

# Liquid formulations for GMP and animal-free preclinical grades of these cytokines are now available. Request further information.

* GMP-grade IL-2, IL-7, and IL-15 are available through our joint venture partnership with ScaleReady.

Manufacturing procedures for these proteins utilize 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.

Read more about our Preclinical Animal-Free Proteins.

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

Key Considerations for Cytokine Supplier Selection for Cell Therapies Thumbnail

Cytokine Supplier Webinar

In this 15-minute webinar, you will learn how effective partnering is central to ensuring end-users' primary considerations of patient safety, lot-to-lot consistency, and supply chain reliability, including tips for choosing your next supplier:

Types of testing you should be looking for to ensure patient safety
How to ensure consistency in cell cultures and controlling for assay variability
Questions to ask to ensure a supplier can meet your needs through later stage trials

Watch Cytokine Supplier Webinar

New! ExCellerate™ GMP iPSC Expansion Medium

For seamless transition from our equivalent RUO iPSC Expansion Medium. Both media support robust expansion and maintenance of pluripotent stem cell culture for enhanced consistency and reproducibility.

Completely animal-free
All-in-one formulation
Stable cell integrity over long term culture

Try Our GMP iPSC Medium

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
USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
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
Viral testing of eukaryotic cell banks and viral reduction studies - Contact us for details
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

This eBook provides an overview of several biological and manufacturing challenges facing the development and production of T cell therapies. It follows with examples of how Bio-Techne products and services can address these challenges at each stage of the process.

Request Your T Cell-Based Therapies eBook