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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.

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

E.coli

IL-10

 

1064-GMP
DMF on file

 

E.coli

IL-15

BT-015-AFL 

BT-015-GMP
DMF on file

Liquid

E.coli

IL-18

 

Coming Soon

 

E.coli

IL-21

BT-021-AFL

8879-GMP

 

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

 

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

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

Transition Seamlessly from RUO to GMP

GMP to RUO Transition Graphs

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

GMP 质检政策和监管支持

我们根据细胞疗法生产工艺中辅助材料监管指南生产 GMP 级细胞因子和生长因子。这包括广泛的质量控制检验和全面的生产系统文档记录以及原材料的可追溯性。您可以确信,您将获得一致、安全和可追溯的原材料供应。我们定期审核自身设施,并欢迎客户审核。

请访问 GMP 生产能力,简要了解我们全球的 GMP 设施认证。

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

Request a Custom GMP Protein