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GMP Proteins for Therapeutic Manufacturing
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Announcing Our New 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 materials including E. coli-derived recombinant proteins.
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.
Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-2
(A) Three independent lots of GMP-grade Recombinant Human IL-2 (R&D Systems, 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
(A) Three independent lots of GMP-grade Recombinant Human IL-7 (R&D Systems, 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).
(A) Three independent lots of GMP-grade Recombinant Human IL-10 (R&D Systems, 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).
GMP and Preclinical Animal-Free Proteins
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GMP Protein (Human) |
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Preclinical Animal-Free Protein |
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CHO |
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E.coli |
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CHO |
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E.coli |
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E.coli |
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E.coli |
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NS0 |
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NS0 |
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E.coli |
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NS0 |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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NS0 |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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E.coli |
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CHO |
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E.coli |
AFL288 coming soon |
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E.coli |
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E.coli |
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CHO |
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* GMP-grade IL-2, IL-7, and IL-15 are available through our joint venture partnership with ScaleReady.
‡ DMF on file.
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
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.
- ISO 9001:2015, ISO 13485:2016-certified facilities including a completely animal-free facility dedicated to manufacturing GMP proteins
- 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
We work with preferred vendors for raw materials to mitigate risk and adhere to a strict definition of animal-free conditions. Certificates of Origin (COOs) are available upon request.
- Individual specification sheets with all testing results, reviewed by both our Quality Control (QC) and Quality Assurance (QA) departments
- Lot-specific Certificates of Analysis
- Full QA review of all batch and bottling records before any material is shipped
- Documented processes and QA control of documentation and process changes
- Personnel training programs
- Raw material testing, tracing, and vendor qualification/monitoring
- Fully validated equipment, processes, and test methods
- Equipment calibration schedules using a computerized calibration program
- Facility maintenance and safety programs
- Material review board for variances
- Stability monitoring over the shelf life of each product
- Product change notifications
We pay strict attention to detail at all levels of the protein manufacturing process. Our quality management systems for GMP proteins include detailed Standard Operating Procedures (SOPs) and quality-controlled documentation of the manufacturing equipment and procedures. You can rely on our GMP proteins for building a consistent and robust cell therapy manufacturing program.
- Biological potency specification
- Defined purity specifications
- Stability testing program
- Defined endotoxin specifications
- Host cell protein content testing
- Sterility testing according to USP
- Viral testing of eukaryotic cell banks and viral reduction studies - Contact us for details
- Additional testing available depending on your needs
We provide each manufactured lot of GMP protein with a Certificate of Analysis (CofA) that documents the relevant quality systems and product specifications. Prior to CofA release, we perform a full QA review of all batch and bottling records. Here is what you can expect to find on our CofAs:
- Actual vial fill (protein mass) for accurate reconstitution
- Source information
- N-terminal sequencing of the first 10 amino acids
- Purity specification
- Bioactivity assay including benchmarking 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
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.
Literature
Key Considerations for Cytokine Supplier Selection for Cell Therapies Article
GMP Cytokines and Growth Factors for Therapeutic Manufacturing Brochure
Website Resources
T Cell Manufacturing for Cell Therapy
Natural Killer (NK) Cells for Cell Therapy
Induced Pluripotent Stem Cells (iPSCs)
