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GMP Solutions

 

We offer recombinant proteins, functional antibodies, and cell culture reagents produced under Current Good Manufacturing Practices (cGMP)* for research, cell processing, and downstream manufacturing needs. Our GMP solutions are manufactured in a dedicated GMP facility*, ensuring products are consistently produced and controlled according to the most updated GMP standards. Our GMP products come with quality documentation and full traceability, under independent Quality Assurance oversight. They also undergo extensive quality control testing for biological activity, purity, stability, concentration, endotoxin, pathogens, sterility, and other tests appropriate to the product type.

 

*BioLegend is ISO 13485:2016 certified, and our GMP facility is ISO 13485:2016 and MDSAP certified.

 

Our operating procedures include:

  • Batch-to-batch consistency
  • Material traceability
  • Documented procedures
  • Documented employee training
  • Equipment maintenance and monitoring records
  • Lot-specific certificates of analysis
  • Quality audits per ISO 13485:2016 and MDSAP
  • QA review of released products

Products for Use in the Cell Bioprocessing Workflow

GMP Reagents Provide Consistency for Bioprocessing

 

GMP Cell Culture Reagents

 

At BioLegend, we understand the critical steps involved in advancing your research from the lab to therapeutics. Our GMP cell culture reagents are manufactured with well-defined components, providing the traceability, controllability, consistency, and safety required in cell processing and downstream manufacturing needs.

 

We provide a choice of formulations to suit different intended applications, experimental goals, and regulatory compliance requirements. Both of our media additives take out the risk and inconsistency of human AB serum in culturing cells: Cell-Vive™ T-NK Xeno-Free Serum Substitute, GMP and Cell-Vive T Cell CD Serum Substitute, GMP. Both are serum-free formulations manufactured under GMP conditions and provide researchers with a higher degree of control and consistency over culture conditions. Both have also been shown to support greater expansion and viability of T and NK cells. The primary distinction between the two is that the Cell-Vive T Cell CD Serum Substitute, GMP is a first-of-its-kind chemically-defined serum substitute without animal-derived components.

 

 

Serum-Free Culturing: Increased Safety, Consistency, and Performance

 

 

Cell-Vive T-NK Xeno-Free Serum Substitute, GMP Cell-Vive T Cell CD Serum Substitute, GMP
Replaces FBS or human AB serum, serum-free Replaces FBS or human AB serum, serum-free
Raw materials may be purified, processed or unprocessed materials from human sources Raw materials that have a known chemical structure and concentration
Xeno-free: contains human serum-derived components, but no components from animals other than humans. No human- or animal-derived components used
Both formulations provide superior T cell expansion compared to other media additives.

Which formulation should you choose? Evaluate both in your cell processing development.

PBMC-derived T cell culture was activated with anti-human CD3, anti-human CD28, and 200 IU/mL of recombinant human IL-2 using IMDM as basal media plus different additives. On indicated days, cells were quantified.

 

Preserving processed cells is a critical stage in the workflow in that it lengthens product shelf-life and allows for transport and storage to/from other sites. Our Cell-Vive CD Low DMSO Cryopreservation Solution, GMP, is specifically formulated to preserve T cells. In addition to low DMSO, it is a serum-free totally-defined formulation, shown to preserve T cell viability and activation after thawing.

 

Following a 9-day expansion protocol using anti-human CD28, anti-human CD3, and IL-2, activated and expanded PBMC-derived T cells were cryopreserved and thawed. Viability, cell recovery, cell expansion, and specific T cell populations were determined.

 

 

 

GMP Cell Culture Ancillary Reagents

 

Our commitment to quality cell cultures includes ancillary reagents for use throughout the bioprocessing workflow. These ancillary reagents are chemically defined and formulated without human or animal components to provide control and consistency over culture conditions.

 

Cell-Vive™ CD Cell Separation Buffer, GMP is a cell separation buffer intended to be used with our MojoSort™ magnetic cell separation system. However, as our representative data show, it works equally well with equivalent cell separation products.

 

 

Human CD3+ cells were isolated from peripheral blood mononuclear cells using Cell-Vive™ CD Cell Separation Buffer. Cells were isolated using a MojoSort™ magnet as indicated in the protocol for MojoSort™ Human CD3 T cell Isolation Kit (A) or using a common commercially available magnetic separation column kit from another supplier (B). Purity was verified, before and after isolation, by staining with Brilliant Violet 421™ anti-human CD3 (clone, UCHT1) and APC anti-human CD56 (clone 5.1H11).

 

 

 

Cell-Vive™ CD Cell Staining Buffer, GMP is an antibody diluent and cell wash buffer optimized for staining of cell suspensions. It is formulated to reduce non-specific binding of antibodies and interference with indirect staining techniques such as biotin/avidin.

 

 

 

Cell viability (A) was tested on PBMCs incubated in Cell-Vive CD Cell Staining Buffer or benchmark staining buffer for 3h at 4°C and analyzed using flow cytometry. Non-specific binding (B) and specific binding (C) of antibodies was tested on PBMCs stained with PE rat IgG2b, ĸ isotype control antibody (clone RTK4530) or PE anti-human HLA-DR (clone LN3) respectively. Flow cytometry stain was performed in presence of Cell-Vive CD Cell Staining Buffer, benchmark, or PBS.

 

 

 

 

Ensure the purity of isolated, enriched cells with Cell-Vive™ Ultra-LEAF™ Defined Human TruStain FcX™, GMP. It effectively blocks the unwanted and non-specific staining caused by FcR-Fc interactions without interfering with specific Fab antibody-mediated staining. Our first-to-market GMP FcR blocking buffer is chemically-defined and serum-free, removing reliance on serum while maintaining control and consistency during characterization and potency analysis of desired cells.

THP-1 cells were treated with Cell-Vive Ultra-LEAF Defined Human TruStain FcX, GMP (purple) followed by staining with an irrelevant mouse IgG2a, ĸ isotype (clone MOPC-173). Non-specific binding on untreated cells is shown in red.

 

 

 

GMP Recombinant Proteins

 

Our GMP recombinant proteins are intended for use in expansion, polarization, and differentiation of cells for research and ex vivo cell processing applications.

 

View all GMP recombinant proteins

 

Each lot of our GMP recombinant proteins undergoes extensive QC testing, including:

  • Biological Activity Validation
  • Purity Testing
  • Concentration Check
  • Endotoxin Testing (<0.1 EU/µg)
  • Bioburden Testing
  • Mycoplasma Testing

 

 

GMP Functional Antibodies

 

Functional antibodies can mimic or interrupt the natural biological effects associated with ligand-receptor interaction. Or, they can directly affect a target cell or molecule. Because of these features, functional antibodies are ideal tools for functional in vitro or in vivo assays.

 

Our GMP Ultra-LEAF™ Purified anti-human CD3 SF Antibody (clone OKT3) is a potent activator of T cells, intended for use in the expansion of T cells for cell bioprocessing or other research applications. This functional antibody is GMP manufactured under serum-free conditions, including serum-free hybridoma cell culture, without additional animal or human-derived materials. Each lot is tested for functional activity measured by T cell expansion.

 

 

As our representative data show, our GMP serum-free OKT3 monoclonal antibody, in combination with anti-CD28, boasts similar bioactivity compared to our non-GMP product, thus ensuring it will be a potent tool for processing cells.

 

PBMC-derived T cells were activated in the presence of Ultra-LEAF anti-human CD28 antibody (Cat. No. 302933) alone, or combined with Ultra-LEAF anti-human CD3 (Cat. No. 317326) or GMP Ultra-LEAF anti-human CD3 SF (Cat. No. 317354) for a period of 4 days. Activation was done via plate coating, with 1 μg/mL of each antibody. Cells were cultured for a total of 10 days, and viable cell number was determined.

 

Glial cell-derived neurotrophic factor (GDNF) is a member of the TGF-β superfamily that signals through GDNF family receptor α-1 (GFRα1) to promote the development, differentiation, and survival of dopaminergic neurons. Because of its neuroprotective nature, GDNF is currently under investigation as a promising therapeutic for the treatment of Parkinson’s disease. Our GMP Ultra-LEAF Purified anti-GDNF antibody (clone A16099G, Cat. No. 670905) inhibits the binding of recombinant human GFRα1 to immobilized recombinant human GDNF (Cat. No. 760402) in a dose-dependent manner, while the isotype control (Cat. No. 401215) does not have the effect. This antibody neutralizes the binding of GFRα1 protein to GDNF, allowing researchers to examine neuronal growth and progression in disease and treatment models.

Recombinant human GFRα1 (black circles) binds to immobilized recombinant human GDNF (Cat. No. 760402). GMP anti-GDNF antibody (purple squares, clone A16099G) inhibits the binding in a dose-dependent manner while the isotype control (grey triangles, Cat. No. 401215) does not have the effect. This antibody blocks the binding of 0.2 µg/mL recombinant human GFRα1 protein to 0.5 μg/mL of immobilized recombinant human GDNF with an ND50 range of 0.05 - 0.4 µg/mL

 

 

 

GMP Flow Cytometry Antibodies

 

Quality control is critical at every step of the cell bioprocessing workflow. Our expanding line of GMP flow cytometry reagents are designed for customers who require higher documentation control when performing clinical research or cell and gene therapy applications. Additionally, our GMP flow cytometry antibodies are very useful to maintain traceability of reagents used in clinical trials and commercial diagnostic kits. They are also helpful in the quality control testing of cell bioprocessing and cell therapy solutions and research.

 

View our GMP flow cytometry antibodies

 

 

Custom Capabilities

 

Emerging therapies involving stem cells, CAR-T, CAR-NK, and others, rely on consistent, quality products for ex vivo manufacturing and quality control. These reagents are crucial for product development and cell bioprocessing applications. We offer GMP recombinant proteins and antibodies as custom products for many of the steps of the cell bioprocessing workflow.

 

Contact our customs team

 

 

Our custom capabilities include:

  • GMP recombinant protein and antibody manufacturing
  • Bulk GMP recombinant proteins and antibodies
  • Recombinant antibodies (partial or full length, species and isotype switching)
  • Custom antibody cocktails in solution or lyophilized
  • Custom antibody conjugations (fluorophores, oligonucleotides, enzymes)
  • Custom immunoassays

 

 

Why consider BioLegend for your custom solutions?

  • Lot sizes and yield to fit your demand (from 1 mg to 1 g)
  • Exclusive US-based development and manufacturing
  • ISO 13485:2016 and MDSAP-certified quality management system
  • Lot-to-lot consistency, fast delivery, and affordability

 

FAQs

 

What is a GMP recombinant protein or antibody?

GMP stands for Good Manufacturing Practice. GMP recombinant proteins and antibodies are manufactured under specific guidelines to ensure product quality and consistency. BioLegend GMP recombinant proteins and antibodies are produced with extensive quality documentation and full material traceability under independent QA oversight.

What is the difference between BioLegend standard RUO and GMP recombinant proteins and antibodies?

BioLegend GMP recombinant proteins and antibodies perform at the same high level as our standard RUO products. No difference in performance should be expected between BioLegend standard RUO and GMP versions. The major difference is the completeness of documentation, material traceability, and independent QA oversight. Additional quality testing may be done depending on the product.

Are BioLegend GMP recombinant proteins or antibodies animal-free?

BioLegend GMP recombinant proteins and antibodies are not animal-free. In all cases where possible, BioLegend attempts to minimize the use of animal components in the manufacturing process. For specific details regarding the use of animal components in the manufacturing process of particular products, please inquire with our technical services team here.

What is the regulatory status and standards for BioLegend GMP recombinant proteins and antibodies?

BioLegend GMP recombinant proteins and antibodies are manufactured in compliance with ISO 13485:2016 and MDSAP. BioLegend GMP recombinant proteins and antibodies are manufactured and tested in accordance with USP Chapter 1043, Ancillary Materials for Cell, Gene, and Tissue Engineered Products and Ph. Eur. Chapter 5.2.12.

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