Select Language
Free Registration
Save Product

GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads
DMF

COADS MS
DS
  • Premium grade (Pre-GMP) version MBS-C001 is now available for seamless transition.

Customer Reviews
Cat. No. / Size
Price
Qty
GMP-MBS001-10mg
$620.00
GMP-MBS001-100mg (10mg X 10)
$1855.00
GMP-MBS001-400mg (10mg X 40)
$5560.00
ETA of in-stock products:2 business days
Sub-Total$ 0
Customize Product
Quote Inquiry

Product Details

  • Product
    Size
    Amount
    GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads
    10 mg
    1×10⁸ beads
    GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads
    100 mg (10 mg×10)
    1×10⁹ beads
    GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads
    400 mg (10 mg×40)
    4×10⁹ beads

  • Features

    1. Designed under ISO 9001:2015 and ISO 13485:2016
    2. Manufactured and QC tested under a GMP compliance factory
    3. FDA DMF filed
    4. Animal-Free materials
    5. Beta-lactam materials free
    6. Batch-to-batch consistency
    7. Stringent quality control tests
    8. GMP grade antibodies as raw materials with strict virus removal steps and testing
    9. GMP grade recombinant HSA as excipient

  • Product Description

    GMP ActiveMax Human T cell Activation/Expansion CD3/CD28 Beads are uniform 5.5 μm of magnetic beads coated with an optimized mixture of GMP grade mouse monoclonal antibodies against the CD3 and CD28, mimicking in vivo stimulation by APCs.
    GMP ActiveMax Human T cell Activation/Expansion CD3/CD28 Beads are Manufactured under a GMP compliance factory with animal free raw materials, and tested under GMP guidelines.

  • Storage

    The product MUST be stored at 2-8°C upon receipt; This product is stable after storage at 2-8°C for 5 years under sterile conditions.

  • Sterility

    Sterility testing was performed using the membrane filtration method in compliance with USP <71> and Ph. Eur. 2.6.1.

  • Endotoxin

    Less than 0.5 EU per mL, tested by the LAL method in compliance with USP <85> and Ph. Eur. 2.6.14.

  • Formulation

    GMP ActiveMax Human T cell Activation/Expansion CD3/CD28 Beads is supplied with 5x10⁷ beads/mL in PBS, pH 7.4, with 0.1% recombinant human serum albumin (recombinant HSA).

  • ACRO Quality Management System

    1. QMS(ISO, GMP)
    2. Quality Advantages
    3. Quality Control Process

Customers Also Viewed

Performance Data

  • Typical Data 

    Please refer to DS document for the assay protocol.

    CD3 & CD28 TYPICAL DATA

    Expansion of the human CD3+T cells. Human T cells using ACROBiosystems CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001) were expanded under two different medium, respectively. Expansion was performed for two weeks, showing that ACROBiosystems’ beads showing better proliferative abilities and comparable competitive ideas compared with competitor product.

  • CD3 & CD28 TYPICAL DATA

    PD-1 expression of the activated human T Cells. The purified human T cells were stimulated using Human T cell Activation/Expansion CD3/CD28 Beads at a ratio of 1:1 beads-to-cells. Cells were expanded in T cell culture medium supplemented with 4ng/mL of rhIL-2 Protein. Activated T cells were expanded for up to 8 days with low PD-1 expression.

  • CD3 & CD28 TYPICAL DATA

    Human CD4+ cells were activated with GMP ActiveMax Human T cell Activation/Expansion CD3/CD28 Beads (Cat. No. GMP-MBS001), and cultured with GMP Human IL-2 Protein (Cat. No. GMP-L02H14), GMP Human TGF-Beta 1 Protein (Cat. No. GMP-TG1H25), Rapamycin, all-trans retinoic acid and sodium butyrate in CelThrea™ GMP T Cell Expansion Medium (Cat. No. Cat. No. GMP-CM3103) for two weeks. The result shows that CelThrea™ GMP T Cell Expansion Medium with GMP ActiveMax Human T cell Activation/Expansion CD3/CD28 Beads, GMP Human IL-2 Protein and GMP Human TGF-Beta 1 Protein can promote the expansion of Treg cells with a reasonable cell viability.

  • CD3 & CD28 TYPICAL DATA

    Human CD4+ cells were activated with GMP ActiveMax Human T cell Activation/Expansion CD3/CD28 Beads (Cat. No. GMP-MBS001), and cultured with GMP Human IL-2 Protein (Cat. No. GMP-L02H14), GMP Human TGF-Beta 1 Protein (Cat. No. GMP-TG1H25), Rapamycin, all-trans retinoic acid and sodium butyrate in CelThrea™ GMP T Cell Expansion Medium (Cat. No. Cat. No. GMP-CM3103) for two weeks. The result shows that CelThrea™ GMP T Cell Expansion Medium with GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads, GMP Human IL-2 Protein and GMP Human TGF-Beta 1 Protein can increase the percentage of the CD4+CD25+CD127lo/-. With the post-culture time, the proportion of CD4+CD25+CD127lo/- cells remained unchanged.

  • Stability

    CD3 & CD28 STABILITY

    The Cell based assay shows that GMP ActiveMax® Human T cell Expansion CD3/CD28 Beads(GMP-MBS001) is stable at 37℃ for 35 days.

  • CD3 & CD28 STABILITY

    Activation of the purified human T Cells. The purified human T cells were activated using Human T cell Activation/Expansion CD3/CD28 Beads, (ACRO, Cat. No. GMP-MBS001/MBS-C001) respectively for 24 hours with CTS Optimizer Medium. Cells were fluorescently stained using PE labeled anti-human CD25 antibody and labeled FITC anti-human CD69 antibody and analyzed by flow cytometry.

  • CD3 & CD28 STABILITY

    Expansion of the human CD3+T cells. Human T cells using ACROBiosystems CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001/MBS-C001) were expanded under two different medium, respectively. Expansion was performed for two weeks, showing that ACROBiosystems’ GMP and PG beads showing similar proliferative abilities.

  • CD3 & CD28 STABILITY

    PD-1 expression of the activated human T Cells. The purified human T cells were stimulated using Human T cell Activation/Expansion CD3/CD28 Beads at a ratio of 1:1 beads-to-cells. Cells were expanded in T cell culture medium supplemented with 4ng/mL of rhIL-2 Protein. Activated T cells were expanded for up to 8 days with low PD-1 expression.

Customer Reviews
Writing Reviews

Important Statement

  • MANUFACTURING SPECIFICATIONS

    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：

    1. Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory
    2. Animal-Free materials
    3. Materials purchased from the approved suppliers by QA
    4. ISO 5 clean rooms and automatic filling equipment
    5. Qualified personnel
    6. Quality-related documents review and approve by QA
    7. Fully batch production and control records
    8. Equipment maintenance and calibration
    9. Validation of analytical procedures
    10. Stability studies conducted
    11. 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:

    1. SDS-PAGE
    2. Protein content
    3. Endotoxin level
    4. Residual Host Cell DNA content
    5. Residual Host Cell Protein content
    6. Biological activity analysis
    7. Microbial testing
    8. Mycoplasma testing
    9. In vitro virus assay
    10. Batch-to-batch consistency

  • ACROBIOSYSTEMS - LEGAL NOTICES FOR GMP GRADE PRODUCTS

    1. PRODUCT USE RESTRICTIONS & PROHIBITIONS

    • 1.1 ACROBiosystems ("ACRO") GMP grade products ("Products") are designed for research, manufacturing use or ex vivo use.
    • 1.2 Products are NOT intended for diagnostic purposes or for direct or indirect administration into humans.
    • 1.3 Purchaser shall not market, distribute, or resell Products obtained from ACRO without ACRO's prior written consent.

    2. REVERSE ENGINEERING PROHIBITED & CONFIDENTIALITY

    • 2.1 Purchaser shall not reverse-engineer, decompile, disassemble, sequence, analyze via bioinformatics, or otherwise attempt to discover the structure, sequence, composition, construction, manufacturing process, or any trade secret embodied in the Products. Purchaser shall not permit any third party to undertake such activities.
    • 2.2 All specifications, data, and know-how related to the Products provided by ACRO are ACRO's confidential information and shall be protected accordingly.

    3. LIMITED WARRANTY & DISCLAIMERS

    • 3.1 ACRO warrants solely that Products will conform to their published specifications when used under normal, specified laboratory/manufacturing conditions and within their labeled expiration date. THIS IS THE ONLY WARRANTY PROVIDED.
    • 3.2 Purchaser assumes ALL risk and responsibility for:
      (a) Determining the suitability of Products for Purchaser's intended application(s).
      (b) Obtaining any necessary regulatory approvals or intellectual property licenses for Purchaser's use.
      (c) Compliance with all applicable laws, regulations (including but not limited to cGMP/GLP where claimed), and industry standards.
      (d) Conducting all necessary quality control, safety, efficacy, and validation testing of Products within Purchaser's process or final product.
      (e) Proper storage, handling, and use of Products according to ACRO's instructions.
    • 3.3 ACRO EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING BUT NOT LIMITED TO: (A) WARRANTIES OF MERCHANTABILITY; (B) WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE; (C) WARRANTIES OF NON-INFRINGEMENT; AND (D) WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.

    4. LIMITATION OF LIABILITY

    • IN NO EVENT SHALL ACRO, ITS AFFILIATES, OR SUPPLIERS BE LIABLE FOR ANY OF THE FOLLOWING, HOWSOEVER ARISING (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, STATUTE, OR OTHERWISE):
      (a) LOST PROFITS, LOST REVENUE, LOST SAVINGS, LOSS OF USE, LOSS OF DATA, BUSINESS INTERRUPTION, OR ANY OTHER INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES.
      (b) ANY DIRECT DAMAGES, COSTS, OR EXPENSES EXCEEDING THE AMOUNT PAID BY PURCHASER FOR THE SPECIFIC PRODUCT(S) GIVING RISE TO THE CLAIM.
      (c) DAMAGES ARISING FROM: (i) MISUSE, ABUSE, OR UNAUTHORIZED MODIFICATION OF PRODUCTS; (ii) USE BEYOND THE EXPIRATION DATE; (iii) IMPROPER STORAGE OR HANDLING; (iv) ACCIDENTAL DAMAGE; (v) FAILURE TO CONDUCT ADEQUATE VALIDATION OR TESTING BY PURCHASER; (vi) INFRINGEMENT CLAIMS RELATED TO PURCHASER'S USE; OR (vii) THE COST OF PROCURING SUBSTITUTE GOODS OR SERVICES.
      (d) ANY PERSONAL INJURY, DEATH, OR DAMAGE TO TANGIBLE PROPERTY TO THE EXTENT PERMITTED BY LAW.

    5. END USER ACKNOWLEDGEMENT & COMPLIANCE

    • 5.1 By accepting, opening, or using the Products, the End User (Purchaser or its downstream recipient) agrees to be irrevocably bound by all terms herein.
    • 5.2 End User explicitly acknowledges the Products are NOT FOR HUMAN ADMINISTRATION and agrees not to use them in any in vivo human application, directly or indirectly.
    • 5.3 End Users unwilling to accept these terms must immediately: (a) cease all use; (b) notify ACRO or their supplier; and (c) return the unopened, unused Products. 5.4 ACRO reserves the right to audit End User's compliance with these restrictions upon reasonable notice

    ACRO has the right, at its sole discretion, to modify, add or remove any terms herein without notice to Purchaser and/or End User. Any changes to these terms are effective immediately following the updating of such changes on ACRO’s website or published specifications or product-related documents

Recent Advances

 
Contact Us
Drug Candidate Licensing
More
  • Basic Product Information
  • Product Details
  • Customers Also Viewed
  • Performance Data
  • Customer Reviews
  • Important Statement