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GMP Proteins for Therapeutic 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

Ensure High Bioactivity, Consistency, and Purity in GMP Cytokines

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.

GMP and Preclinical Animal-Free Proteins

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

 

FGF basic (145 aa)

E.coli

AFL3718

Flt-3 Ligand/FLT3L

E.coli

AFL308E

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

AFL204

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

AFL255

Sonic Hedgehog (C24II) N-Terminus

E.coli

AFL1845

Sonic Hedgehog N-Terminus

E.coli

 

TGF-beta 1

CHO

 

Thrombopoietin

E.coli

AFL288 coming soon

TNF-alpha

E.coli

AFL210

VEGF

E.coli

BT-VEGF-AFL

Wnt-3a

CHO

 

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

‡ DMF on file.

 

Visit ScaleReady to Learn More

What is an Animal-Free Protein?

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.

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
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

GMP Quality Policy and Regulatory Support

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.

T Cell-Based Therapies eBook

T Cell-Based Therapies eBook

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 a Custom GMP Protein