Medica 2026
Nov 16-19, 2026 - Düsseldorf, Germany

GMP-Grade Recombinant Proteins for Cell & Gene Therapy Applications

Introduction

Cell and gene therapy (CGT) is revolutionizing the treatment of genetic disorders, cancer, and degenerative diseases. A critical factor in successful CGT development is the availability of GMP-grade recombinant proteins, including cytokines, growth factors, enzymes, and viral vector-associated proteins. Our GMP-grade protein portfolio delivers high-quality, clinical-grade materials suitable for research, preclinical studies, and clinical applications.

Key Highlights:

With decades of expertise in recombinant protein production, our facility leverages advanced bioprocessing technologies to maintain consistent performance across all protein classes. Each protein is meticulously engineered to preserve structural integrity and functional activity, forming a solid foundation for robust CGT development.

What Are GMP-Grade Recombinant Proteins?

GMP-grade recombinant proteins are biologically active proteins manufactured under Good Manufacturing Practice (GMP) standards. They differ from research-grade reagents in several key aspects:

These proteins are essential in various CGT workflows, providing reproducibility, potency, and safety. From T cell expansion to viral vector assembly, GMP-grade proteins serve as the backbone of scalable and regulatory-compliant cell therapy manufacturing.

Applications Include:

Standardizing protein source and quality reduces variability between batches and laboratories, ensuring reliable outcomes for both preclinical and clinical programs.

Platform Features & Product Advantages

1. High Purity and Structural Integrity

Proteins undergo rigorous purification, including multi-step chromatography and filtration, to minimize contaminants and ensure optimal folding. Structural integrity is confirmed via biophysical methods such as circular dichroism, differential scanning calorimetry, and mass spectrometry.

2. Animal-Origin-Free (AOF) Production

Eliminating animal components reduces contamination risks, enhances reproducibility, and aligns with regulatory standards, ensuring patient safety for clinical applications.

3. Consistent Bioactivity

Each batch undergoes a comprehensive bioactivity assessment tailored to its application.

4. Scalable Manufacturing

Production capabilities accommodate both small-scale research and full-scale clinical manufacturing, with standardized processes ensuring reproducibility from pilot to commercial runs.

Applications in CGT

1. T Cell Therapy (CAR-T, TCR-T)

Fig. 1 Cytokines and activation proteins are critical for T cell proliferation, persistence, andfunctionality Schematic illustrating how cytokines and activation proteins enhance engineered T cell proliferation, persistence, and antitumor function. IL-2 promotes T cell expansion, IL-7 and IL-15 support memory phenotype and long-term survival, and anti-CD3/CD28 proteins provide activation and co-stimulatory signals for optimal therapeutic activity.Fig. 1 Cytokines and activation proteins are critical for T cell proliferation, persistence, and functionality

2. Stem Cell and iPSC Culture

Fig. 2 GMP recombinant proteins support stem cell differentiation, expansion, and maintenance Diagram showing how GMP recombinant proteins regulate stem cell maintenance, expansion, and differentiation. FGF2 maintains pluripotency and self-renewal, TGF-β family proteins control lineage commitment, and BMPs direct differentiation into specialized cell types from pluripotent stem cells or iPSCs.Fig. 2 GMP recombinant proteins support stem cell differentiation, expansion, and maintenance

3. Viral Vector Production

4. Genome Editing and CRISPR Systems

5. Exosome and Nanomedicine Development

Product Portfolio Overview

Stem Cell Expansion & Maintenance: bFGF, EGF, TGF-β1, and other growth factors for efficient proliferation while maintaining pluripotency.

Cat.ProductMWSourceEndotoxinBioactivity
DAG-WT6143Human FGF217 kDaE. coli≤10EU/mgMaintains iPSC pluripotency
DAG-WT6170Human TGF-β112.8 kDaHEK293 cells≤10 EU/mgPromotes stem cell self-renewal
DAG-WT6142Human Activin A12.9 kDaCHO cells≤10EU/mgSupports pluripotency and differentiation
DAG-WT6147Human BMP-713.1 kDaCHO cells≤10 EU/mgGuides differentiation toward specific lineages
DAG-WT6160Human LIF19.7 kDaCHO cells≤10 EU/mgMaintains pluripotency and promotes proliferation

Extracellular Matrix (ECM) Series: Fibronectin, Vitronectin, Laminin for stable growth microenvironments.

Cat.ProductMWSourceEndotoxinBioactivity
DAG-WT6213Human Fibronectin (FN)206 kDaHEK293 cells≤10EU/mgSupports cell adhesion, migration, and proliferation
DAG-WT6219Human Vitronectin (VN)52.3 kDaCHO cells≤1 EU/mgPromotes attachment and maintenance of pluripotent stem cells

Immune Cell Culture: Cytokines (IL-2, IL-7, IL-15, IL-21) and monoclonal antibodies for immune cell expansion and activation.

Cat.ProductMWSourceEndotoxinBioactivity
DAG-WT6188Human IL-215.4 kDaCHO cells≤10EU/mgPromotes T cell proliferation
DAG-WT6193Human IL-717.3 kDaCHO cells≤10 EU/mgEnhances memory T cell survival
DAG-WT6197Human IL-1512.7 kDaCHO cells≤10 EU/mgSupports NK and T cell expansion
DAG-WT6200Human IL-2115.9 kDaCHO cells≤10 EU/mgPromotes proliferation and differentiation of T and B cells; enhances NK cell cytotoxicity

Quality Control and Release Testing

ParameterMethodSpecification
PuritySDS-PAGE / HPLC≥95%
IdentityMass spectrometryConfirmed
EndotoxinLAL assay≤0.1 EU/μg
SterilityUSP<71>No growth
BioactivityCell-based assayWithin spec
Residual DNAqPCRBelow regulatory limits

Additional testing includes stability, molecular weight confirmation, N-terminal sequencing, and functional validation.

Regulatory Compliance & Documentation

Advantages Over Research-Grade Proteins

FeatureResearch GradeGMP Grade
Manufacturing standardNon-GMPGMP
TraceabilityLimitedFull
DocumentationBasicCoA, CoO, GMP records
Batch consistencyVariableHigh
Clinical suitabilityNoYes

Why Choose Our GMP Protein Platform?

  1. End-to-End CGT Support: from discovery to commercial manufacturing
  2. Proven Performance: validated in CAR-T, stem cell, viral vector, and genome editing workflows
  3. Customizable Options: tag-free, Fc-fusion, glycoengineered, stabilized proteins
  4. Reliable Supply Chain: long-term batch reservation and global distribution
  5. Scalable Manufacturing: flexible production platforms
  6. Comprehensive Documentation: CoA, CoO, and functional data for all lots

FAQs

Antibody FAQs

Still have questions?

Contact Us

Yes, each production batch includes comprehensive analytical and quality documentation for traceability and consistency.

Yes, produced in chemically defined media.

Yes, including expression system selection, codon optimization, and scale-up.

References

  1. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  2. Wang, X., et al. "Cytokine optimization in CAR-T therapy manufacturing." Nature Reviews Drug Discovery, 2024.
  3. Milone, M.C., & O'Doherty, U. "Clinical use of lentiviral vectors." Leukemia, 2018.
  4. Wright, J.F., "Manufacturing and characterizing AAV-based vectors." Gene Therapy, 2020.
  5. Esposito, K., et al., "Automated ELISA platforms for antigen characterization." Vaccine: X, 2025.
  6. Prasad, V., et al., "GMP-grade recombinant cytokines in T cell culture for clinical CAR-T manufacturing." Cytotherapy, 2021.
  7. Chen, J., et al., "Large-scale production of GMP recombinant IL-2 for clinical applications." Biotechnology and Bioengineering, 2020.
  8. Zhao, Y., et al., "GMP-compliant production of Cas9 nucleases for genome editing." Molecular Therapy, 2022.
  9. Lee, J., et al., "Clinical-grade FGF2 and TGF-β for stem cell maintenance under GMP conditions." Stem Cell Research & Therapy, 2019.
  10. Smith, A., et al., "Quality control and release criteria for GMP recombinant proteins in cell therapy applications." Journal of Translational Medicine, 2021.
  11. Patel, S., et al., "Scalable production of lentiviral vectors using GMP recombinant proteins." Human Gene Therapy Methods, 2020.
  12. Gupta, R., et al., "Endotoxin reduction strategies in GMP cytokine production." Bioprocess International, 2019.
  13. Johnson, K., et al., "Regulatory perspectives on GMP recombinant proteins for clinical applications." Biotechnology Journal, 2021.
  14. Tan, W., et al., "Advances in GMP production of growth factors and cytokines for stem cell therapy." Frontiers in Bioengineering and Biotechnology, 2022.
  15. Davis, H., et al., "Functional assays for validating GMP recombinant protein activity." Cytotherapy, 2020.

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