Good Manufacturing Practices (GMP)-grade Proteins

GMP Proteins – Animal-Free GMP Proteins – ACFP GMP Proteins – Protein Manufacturing
 

As the promise of cellular therapies grows, so does the need for high-quality raw material and ancillary components for ex vivo cell manufacturing, including GMP cytokines and growth factors. Our large supply of GMP proteins is backed by our dedication to providing cell therapy manufacturers a consistent, safe, and traceable supply of reagents. View our GMP protein portfolio below and our cell and gene therapy manufacturing portfolio at bio-techne.com.

View all Proteins Proteins by Cell Type Lot-to-Lot Consistency COA Specifications FAQs Quality & Regulatory Policy

Full transparency and traceability of source and manufacturing system is necessary for building a cell therapy product. This GMP protein list includes the cell source and whether the protein was manufactured using an animal-free process.

Announcing Our New State-of-the-Art GMP Protein Manufacturing Facility!

Read About Our New Facility
 

Learn About Our New Facility

Animal-Free GMP and Animal-Free Preclinical Proteins

Protein (Human) Source Catalog # GMP Animal-Free DMF Filed For GMP Catalog # Preclinical Animal-Free
Betacellulin E.coli BT-BTC-GMP   BT-BTC-AFL
BMP-4 E.coli 314E-GMP   AFL314E
EGF E.coli 236-GMP Yes  
FGF basic (145 aa) E.coli 3718-GMP   AFL3718
Flt-3 Ligand/FLT3L E.coli 308E-GMP Yes AFL308E
GM-CSF E.coli 215-GMP   AFL215
IFN-γ E.coli 285-GMP Yes AFL285
IGF-I E.coli 291-GMP   AFL291
IL-1β E.coli 201-GMP   AFL201
IL-2 E.coli BT-002-GMP   BT-002-AFL
IL-3 E.coli 203-GMP   AFL203
IL-4 E.coli 204-GMP Yes AFL204
IL-6 E.coli 206-GMP   AFL206
Protein (Human) Source Catalog # GMP Animal-Free DMF Filed For GMP Catalog # Preclinical Animal-Free
IL-7 E.coli BT-007-GMP   Yes BT-007-AFL
IL-10 E.coli 1064-GMP    
IL-15 E.coli BT-015-GMP Yes BT-015-AFL
IL-21 E.coli 8879-GMP Yes AFL8879
LR3 IGF-I E.coli 8335D-GMP    
M-CSF E.coli 216-GMP   AFL216
PDGF-AA E.coli 221-GMP   AFL221
PDGF-BB E.coli 220-GMP   AFL220
SCF/c-kit Ligand E.coli 255B-GMP Yes AFL255
Sonic Hedgehog (C24II) N-Terminus E.coli 1845-GMP   AFL1845
Sonic Hedgehog N-Terminus E.coli 1314-GMP    
Thrombopoietin E.coli 288E-GMP   AFL288 coming soon
TNF-α E.coli 210-GMP   AFL210

GMP Proteins

Protein (Human) Source Catalog # GMP DMF Filed For GMP
Activin A CHO 338-GMP Yes
BMP-2 CHO 355-GMP  
GDF-8/Myostatin NS0 788-GMP  
GDNF NS0 212-GMP  
HGF NS0 294-GMP  
Protein (Human) Source Catalog # GMP DMF Filed For GMP
KGF/FGF-7 E.coli 251-GMP  
Noggin Fc Tag NS0 3344-GMP  
TGF-β1 CHO 240-GMP  
Wnt-3a CHO 5036-GMP  

ScaleReady

Bio-Techne believes in the power of partnerships. We have joined with Fresenius Kabi and Wilson Wolf to bring you ScaleReady™, lowering the barriers to entry into the immune cell therapy space for all sizes and stages of manufacturing programs. ScaleReady brings cell and gene therapies to life by offering a significant reduction of complexity and cost while consistently providing superior repeatability and cell quality.

The ScaleReady product portfolio supports scalable immune cell therapy solutions using GMP IL-2, IL-7, IL-15, and IL-21, delivering true platform, process, and product continuity for your immune cell programs. When paired with the Lovo® and Cue® functionally-closed-system automated cell processing systems, Bio-Techne reagents and the G-Rex® Bioreactor enable high throughput parallel processing of cell therapies within a small footprint.

Contact ScaleReady Protocol and Process Optimization Experts

GMP Proteins by Cell Type

Advanced cell therapies using immune cells (CAR T or Natural Killer Cells) and stem cells are rapidly progressing through clinical trials. Find the GMP raw materials you need by specific cell type.

 
 

 

Current Products Available from Our New State-of-the Art GMP Protein Manufacturing Facility

GMP-grade Recombinant Human Betacellulin, GMP-grade Recombinant Human IL-2, GMP-grade Recombinant Human IL-7, GMP-grade Recombinant Human IL-10, and GMP-grade Recombinant Human IL-15 are now being produced in our new St. Paul GMP Manufacturing Facility.

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

Analysis of the activity, lot-to-lot consistency and purity of R&D Systems GMP-grade Recombinant Human IL-2 protein

(A) Three independent lots of GMP-grade Recombinant Human IL-2 (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.

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

Analysis of the activity, lot-to-lot consistency and purity of R&D Systems GMP-grade Recombinant Human IL-7 protein

(A) Three independent lots of GMP-grade Recombinant Human IL-7 (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).

Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-10

Analysis of the activity, lot-to-lot consistency and purity of R&D Systems GMP-grade Recombinant Human IL-7 protein

(A) Three independent lots of GMP-grade Recombinant Human IL-10 (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)

 

Lot-to-Lot Consistency 

As you scale your clinical manufacturing process, it often becomes necessary to use GMP growth factors and cytokines from different lots. Because these reagents are made in biological systems, different lots can be susceptible to variability. Over decades of experience, R&D Systems has developed a mature quality management system and detailed protocols that allow for the manufacture of recombinant proteins with industry-leading consistency. Each new lot must pass stringent quality control specifications for activity in a well-defined bioassay. New lots are also tested against a master lot to control for assay variability. Lot-specific activity information can be found on each product certificate of analysis (C of A) and lot-to-lot sample data is available by request.

 

Recombinant Human IL-21

Three independent lots of GMP-grade Recombinant Human IL-21 (Catalog # 8879-GMP) were tested for activity. IL-21 stimulates IFN-gamma secretion in NK-92 human natural killer lymphoma cells. Each trace represents data obtained using GMP IL-21 from a different manufacturing run.

Recombinant Human Noggin

Three independent lots of GMP-grade Recombinant Human Noggin (Catalog # 6057-GMP) were tested for activity. Noggin inhibits BMP-4-induced alkaline phosphatase production in the ATDC5 mouse chondrogenic cell line. Each trace represents data obtained using GMP Noggin from a different manufacturing run.  

Analysis of the activity and lot-to-lot consistency of R&D Systems GMP-grade Recombinant Human Flt-3 Ligand

Three independent lots of GMP-grade Recombinant Human Flt-3 Ligand/FLT3L (Catalog # 308E-GMP) were tested for their activity in a cell proliferation assay. Flt-3 Ligand stimulates dose-dependent proliferation of the BaF3 mouse pro-B cell line transfected with mouse Flt-3. Each trace represents data obtained using GMP Flt-3 Ligand from a different manufacturing run.

 

Certificate of Analysis Specifications

Each lot of GMP protein manufactured comes with a Certificate of Analysis (CofA) that documents the quality systems and product specifications. Prior to protein CofA release, a full QA review of all batch and bottling records is performed. Please see the CofA for product-specific testing and guidelines.

  • Source information
  • N-terminal sequencing of the first 10 amino acids
  • Purity Specification
  • Bioactivity assay including testing 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, including:
    • ISO 9001:2015, ISO 13485:2016-certified facility
    • 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

 

 

GMP Protein FAQs

What is a GMP Protein?

The proteins are manufactured under guidelines that allow for their use as ancillary materials in cell therapy or for further manufacturing processes. GMP proteins also come with extensive documentation and traceability, as well as additional quality control testing. They may or may not be manufactured using animal-free processes depending on the characteristics of the protein.

What is the Difference Between R&D Systems Traditional Proteins and GMP Versions?

Often the sequence, the expression system, and the basic manufacturing SOP for traditional and GMP proteins are the same. This makes the transition from using research-use proteins to GMP as seamless as possible. In addition, compared to traditional proteins, GMP proteins come with extensive documentation for traceability as well as additional quality control testing and quality assurance review.

What Should I Expect from a GMP Protein Manufacturer?

Some basic things to expect include a lot-specific Certificate of Analysis that will detail the identity of the protein and analytical testing that has been done to ensure the material is meeting specifications. A Certificate of Origin may be obtained that provides traceability of the materials used in manufacturing of the protein. This would be key document for those wanting to establish they are working with animal-free raw materials. Drug Master Files (DMFs) may also be submitted to regulatory authorities by the supplier. DMFs provide details about manufacturing process and can be referenced during filing. They also provide a mechanism for submitting proprietary information. A supplier should be very open to audits of their facilities where you can review batch records that provide critical information about lot-to-lot consistency. Lastly, look for a protein manufacturer with a mature quality management system (QMS), including GMP and quality experience, who can be an asset as you move through the manufacturing process.

When Should I Transition to GMP?

Moving to GMP proteins as early as possible, potentially even during research and development work, is the best course. This is especially the case if you are using cytokines or growth factors from a supplier that doesn’t also offer GMP cytokines and growth factors for further manufacturing.

Where are Your GMP Proteins Made?

We manufacture all R&D Systems GMP proteins at our headquarters in Minnesota. We’re committed to providing the best GMP proteins on the market, and we’ve just opened a brand new state-of-the-art manufacturing facility to meet the increasing demands of therapeutic cell manufacturing. Learn about our new GMP manufacturing facility.

Are R&D Systems GMP Proteins Animal-free?

If possible, R&D Systems GMP proteins are made in an entirely animal-free process using E. coli as the source. However, there are some proteins that require production in eukaryotic systems to maintain activity. This may be due to protein folding or post-translational modifications that can only be accomplished by making the protein in a eukaryotic cell line. In all cases, it is clearly stated on the website whether a specific protein is produced in an animal-free process. See our safety page for a detailed definition of our animal-free process. View our Animal-free Proteins.

Are GMP proteins from R&D Systems Pharmaceutical or Therapeutic-grade?

No, our GMP proteins can only be used as raw materials or ancillary reagents for cell culture or other processes involved in ex vivo manufacturing.

Do You Have Drug Master Files?

Drug Master Files (DMFs) are kept on record in the United States at the FDA. These records detail all aspects of the manufacturing, including proprietary processes. They can be accessed to support new submissions. R&D Systems is in the process of submitting DMFs for all GMP cytokines and growth factors. Please contact us for detailed information on your protein of interest.

Do You Run Cell-based Assays to Test GMP Protein Performance?

Each GMP cytokine and growth factor is tested for performance using cell-based bioassays that include proliferation, induced cytokine secretion, cytotoxicity, and others. Details regarding activity testing for a given cytokine are regularly shared during audits of our facilities.