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CytoPak GMP Human IL-2 Protein is packaged in sterile closed containers that can be readily incorporated into ex vivo clinical production processes. The bag utilizes medical grade multilayer film with two weldable options. The outlet weldable tube contains a proximal TPE section (1/8’’ ID x 1/4’’ OD) and a distal PVC section (3/32’’ ID x 5/32’’ OD). The liquid state and closed-system packaging of CytoPak GMP Human IL-2 Protein can be directly welded to GMP media bags resulting in safety and user-friendliness by bypassing the reconstitution step during manufacture.
This protein carries no "tag".
The protein has a calculated MW of 15.4 kDa. The protein migrates as 16 kDa±2 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE).
>95% as determined by SDS-PAGE.
Supplied as 0.2 μm filtered solution in phosphate with protectants.
Contact us for customized product form or formulation.
This product is supplied and shipped with dry ice, please inquire the shipping cost.
Upon receipt, store it immediately at -70°C or lower for long term storage.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
CytoPak GMP Human IL-2 Protein on SDS-PAGE under reducing (R) and non-reducing (NR) conditions. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95% (With Star Ribbon Pre-stained Protein Marker).
CytoPak GMP Human IL-2 Protein (Cat. No. GMP-L02H14GB01) stimulates proliferation of CTLL-2 cells. The specific activity of CytoPak GMP Human IL-2 Protein is ≥1.20 x 10^7 IU/mg, which is calibrated against human Interleukin-2 China National Standard (NIFDC code: 270008) (QC tested). China National Institutes for Food and Drug Control (NIFDC) Standard was prepared and calibrated against human IL-2 WHO International Standard (NIBSC code: 86/500) by NIFDC.
Human PBMCs were cultured with lyophilized GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) or CytoPak GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14GB01) with CelThrea™ GMP T Cell Expansion Medium (ACROBiosystems) for two weeks. No significant differences were observed in cell viability or proliferation between lyophilized and CytoPak IL-2. Data is the average of 3 independent experiments, error bars ±SD.
Human PBMCs were cultured with lyophilized GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) or CytoPak GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14GB01) with CelThrea™ GMP T Cell Expansion Medium (ACROBiosystems) for two weeks. No significant differences were observed in the ratio of CD3+ or CD3+ CD4/CD8 positive cells between lyophilized and CytoPak IL-2. Data is the average of 3 independent experiments, error bars ±SD.
The Cell based assay shows that CytoPak GMP Human IL-2 Protein (Cat. No. GMP-L02H14GB01) is stable at 25°C for 65 hours.
The Cell based assay shows that CytoPak GMP Human IL-2 Protein (Cat. No. GMP-L02H14GB01) is stable after freezing and thawing 3 times.
ACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP<92>Growth Factors and Cytokines Used in Cell Therapy Manufacturing; USP<1043>Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products.
ACROBiosystems Quality Management System Contents:
Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory
Animal-Free materials
Materials purchased from the approved suppliers by QA
ISO 5 clean rooms and automatic filling equipment
Qualified personnel
Quality-related documents review and approve by QA
Fully batch production and control records
Equipment maintenance and calibration
Validation of analytical procedures
Stability studies conducted
Comprehensive regulatory support files
Request For Regulatory Support Files(RSF)
ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meet stringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:
SDS-PAGE
Protein content
Endotoxin level
Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
Microbial testing
Mycoplasma testing
In vitro virus assay
Batch-to-batch consistency
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English Name | Research Code | Research Phase | Company | First Brand Name | First Approved Country | First Indication | First Approved Company | First Approved Date | Indications | Clinical Trials |
---|---|---|---|---|---|---|---|---|---|---|
Thalidomide | NSC-66847; NSC-527179; K-17; FPF-300; FPF300 | Approved | Celgene Corp | Talizer, Thalidomide Celgene, Thalidomide Pharmion, Synovir, Thalomid, Thaled | Mainland China | Leprosy, Lepromatous; Multiple Myeloma | Changzhou Pharmaceutical Factory | 1982-01-01 | Xerostomia; Colorectal Neoplasms; Neuroectodermal Tumors, Primitive; Prostatitis; Primary Myelofibrosis; Osteosarcoma; Cholangitis, Sclerosing; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Adenocarcinoma, Clear Cell; Carcinoma, Adenosquamous; Epilepsy; Erythema Nodosum; Sarcoma; HIV Wasting Syndrome; Pancreatitis, Chronic; Sarcoma, Ewing; Arachnoiditis; Gastrointestinal Hemorrhage; Retinoblastoma; Prostatic Neoplasms; Endometriosis; Lung Neoplasms; Leukemia, Lymphocytic, Chronic, B-Cell; Vascular Malformations; Myelodysplastic-Myeloproliferative Diseases; Mycobacterium avium-intracellulare Infection; Amyotrophic Lateral Sclerosis; Carcinoma, Hepatocellular; Burning Mouth Syndrome; Stomatitis; Neoplasm Metastasis; Appendiceal Neoplasms; Tuberculosis; Lymphoma, Non-Hodgkin; Angiodysplasia; Pelvic Pain; Glioma; Waldenstrom Macroglobulinemia; Leprosy, Lepromatous; Endometrial Neoplasms; Uterine Neoplasms; Anemia, Sideroblastic; Ovarian Neoplasms; Gastric Antral Vascular Ectasia; Lupus Erythematosus, Discoid; Carc | Details |
English Name | Research Code | Research Phase | Company | Indications | Clinical Trials |
---|---|---|---|---|---|
Darleukin/fibromun | L19-IL-2/ L19-TNF-α | Phase 3 Clinical | Philogen Spa | Carcinoma, Merkel Cell; Carcinoma, Basal Cell; Carcinoma, Skin Appendage; Keratoacanthoma; Basal Cell Nevus Syndrome; Carcinoma, Squamous Cell; Lymphoma, T-Cell, Cutaneous; Melanoma; Sarcoma, Kaposi | Details |
Bifikafusp alfa | L19-IL-2 | Phase 3 Clinical | Philogen Spa | Solid tumours; Adenomatous Polyposis Coli; Pancreatic Neoplasms; Melanoma; Carcinoma, Non-Small-Cell Lung | Details |
EQ-101 | EQ101; EQ-101; BNZ132-1-40; BNZ-1; BNZ132-1; BNZ-01 | Phase 2 Clinical | Bioniz Therapeutics Inc | Alopecia; Alopecia Areata; Lymphoma, T-Cell, Cutaneous; Leukemia, Large Granular Lymphocytic | Details |
umitrelimorgene autodencel | ITI-1000 | Phase 2 Clinical | Immunomic Therapeutics Inc | Glioblastoma | Details |
S-95007 | S-95007 | Phase 2 Clinical | Laboratoires Servier | Immune System Diseases; Inflammation | Details |
AU-007 | BD-8; AU-007; BDG-8 | Phase 2 Clinical | Biolojic Design Inc | Solid tumours; Neoplasms; Neoplasm Metastasis | Details |
XTX-202 | XTX-202 | Phase 2 Clinical | Xilio Development Inc, Xilio Therapeutics Inc | Solid tumours; Carcinoma, Renal Cell; Melanoma | Details |
EGL-001 | EGL-001 | Phase 2 Clinical | Egle Therapeutics | Solid tumours; Neoplasms | Details |
STI-7349 | STI-7349 | Phase 2 Clinical | The Fourth Affiliated Hospital, Zhejiang University School Of Medcine | Solid tumours | Details |
LAT-010 | LAT010; LAT-010 | Phase 2 Clinical | Latticon Antibody Therapeutics Inc | Solid tumours; Neoplasm Metastasis | Details |
COYA-302 | COYA302; COYA 302; COYA-302 | Phase 2 Clinical | Coya Therapeutics Inc | Parkinson Disease; Frontotemporal Dementia; Amyotrophic Lateral Sclerosis | Details |
KB-707 | KB707; KB-707 | Phase 2 Clinical | Krystal Biotech Inc | Solid tumours; Skin Melanoma; Neoplasms; Lung Neoplasms; Melanoma; Carcinoma, Non-Small-Cell Lung | Details |
REGN-10597 | REGN-10597 | Phase 2 Clinical | Regeneron Pharmaceuticals Inc | Solid tumours; Carcinoma, Renal Cell; Neoplasms; Melanoma | Details |
IBI-363 | IBI-363 | Phase 2 Clinical | Innovent Biologics(Suzhou) Co Ltd | Solid tumours; Stomach Neoplasms; Carcinoma, Renal Cell; Neoplasms; Colorectal Neoplasms; Lymphoma; Carcinoma, Non-Small-Cell Lung; Melanoma | Details |
Saltikva | MDB401B | Phase 2 Clinical | Salspera LLC, Sunshine Lake Pharma | Pancreatic Neoplasms | Details |
LMBP2-specific TCR-T cell therapy (TCRCure Biopharma) | Phase 2 Clinical | Tcrcure Biopharma Ltd | Nasopharyngeal Carcinoma | Details | |
Interleukin-2 gene therapy (St Jude Children's Research Hospital) | Phase 1 Clinical | St. Jude Children'S Research Hospital, National Cancer Institute | Neuroblastoma | Details | |
T20K | T-20K | Phase 1 Clinical | Cyxone | Multiple Sclerosis | Details |
ODC-IL2 | ODC-IL2; ODC-IL-2 | Phase 1 Clinical | Trutino Biosciences Inc | Solid tumours; Neoplasms | Details |
SIM-0278 | ALM-223; SIM0278 | Phase 1 Clinical | Simcere Pharmaceutical Group Ltd | Autoimmune Diseases; Lupus Erythematosus, Systemic; Dermatitis, Atopic | Details |
Mableukin 2PD1 (Anwita Biosciences) | AWT020; AWT-020 | Phase 1 Clinical | Anwita Biosciences Inc | Neoplasms; Autoimmune Diseases of the Nervous System | Details |
AB-248 | AB-248 | Phase 1 Clinical | Asher Biotherapeutics Inc | Solid tumours; Carcinoma, Renal Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung; Melanoma | Details |
ASP-1012 | VET2-L2; ASP-1012; ASP1012 | Phase 1 Clinical | KaliVir Immunotherapeutics Inc | Solid tumours | Details |
STK-012 | STK-012 | Phase 1 Clinical | Synthekine Inc | Solid tumours; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Renal Cell; Esophageal Neoplasms; Stomach Neoplasms; Mismatch Repair Deficient Cancer; Carcinoma, Transitional Cell; Microsatellite instability-high cancer; Uterine Cervical Neoplasms; Carcinoma, Non-Small-Cell Lung; Melanoma | Details |
TEV-278 | TEV-278; TEV-‘278 | Phase 1 Clinical | Teva Pharmaceutical Industries Ltd | Neoplasms | Details |
HM-16390 | HM-16390; HM16390 | Phase 1 Clinical | Hanmi Pharmaceutical Co Ltd | Solid tumours | Details |
IL2 CD25 fusion protein (Bristol-Myers Squibb) | Phase 1 Clinical | University Of Miami | Autoimmune Diseases | Details | |
M5A-IL2 Immunocytokine | M5A-ICK | Phase 1 Clinical | National Cancer Institute, City Of Hope National Medical Center | Breast Neoplasms; Colorectal Neoplasms | Details |
DF-6215 | DF6215; DF-6215 | Phase 1 Clinical | Dragonfly Therapeutics Llc | Solid tumours | Details |
Dodekin | Phase 1 Clinical | Philogen Spa | Solid tumours | Details | |
AttIL2-T cell therapy | Phase 1 Clinical | The University Of Texas MD Anderson Cancer Center | Soft Tissue Neoplasms; Osteosarcoma; Sarcoma | Details | |
Autologous tumor-infiltrating lymphocyte cells therapy (Hervor Therapeutics) | HV-101; HV101 | Phase 1 Clinical | Hervor Therapeutics, Tcrcure Biopharma Ltd, Hangzhou Houwu Biomedical Technology Co Ltd | Solid tumours | Details |
KY-0118 | KY-0118; KY0118 | Phase 1 Clinical | Novatim Immune Therapeutics (Zhejiang) Co Ltd | Solid tumours; Carcinoma, Renal Cell; Carcinoma, Transitional Cell; Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms; Melanoma; Carcinoma, Non-Small-Cell Lung | Details |
VIS171 | VIS-171; VIS171 | Phase 1 Clinical | Visterra Inc | Alopecia Areata; Autoimmune Diseases; Glomerulosclerosis, Focal Segmental; Lupus Erythematosus, Systemic | Details |
MK-1484 | MK-1484; SP-482 | Phase 1 Clinical | Merck & Co Inc, Sutro Biopharma Inc | Solid tumours | Details |
SAR-444336 | SAR-444336 | Phase 1 Clinical | Sanofi | Inflammation | Details |
RS-2102 | RS2102 | Phase 1 Clinical | Reistone Biopharma Co Ltd | Dermatitis, Atopic | Details |
RG-6279 | RG-6279 | Phase 1 Clinical | F. Hoffmann-La Roche Ltd | Solid tumours | Details |
BNT-153 | BNT-153 | Phase 1 Clinical | Biontech Se | Solid tumours | Details |
Igrelimogene litadenorepvec | PM-1016; PM1016; TILT-123 | Phase 1 Clinical | Tilt Biotherapeutics Ltd | Ovarian Neoplasms; Solid tumours; Squamous Cell Carcinoma of Head and Neck; Peritoneal Neoplasms; Fallopian Tube Neoplasms; Lung Neoplasms; Carcinoma, Hepatocellular; Melanoma | Details |
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