GMP Cellectra™ Human CD4 NanoSort Microbeads

Product Description

GMP Cellectra™ Human CD4 NanoSort Microbeads are dextran-coated superparamagnetic iron oxide nanoparticles of which the surface is conjugated with recombinant monoclonal antibodies specific to human CD4. They are especially designed for positive selection or depletion of CD4+ cells.
ACROBiosystems performs rigorous quality control tests on our GMP-grade products (using fully validated equipment, processes, and test methods) to ensure that they meet stringent standards in terms of safety, activity, and inter-batch stability.

Application

GMP Cellectra™ Human CD4 NanoSort Microbeads are designed for the positive selection or depletion of CD4⁺ T cells from fresh or cryopreserved peripheral blood mononuclear cells (PBMCs), leukapheresis products, or single-cell suspensions. CD4, also known as T4 and Leu3, is a member of the immunoglobulin superfamily expressed on the majority of thymocytes and on a subset of peripheral blood T lymphocytes (helper/inducer T cells). The magnetic Microbeads are conjugated with monoclonal antibodies targeting human CD4 protein, enabling CD4+ cells to be labeled with the specific antibodies and magnetic particles, and separated using separation equipment.

Storage

This product is supplied as a sterile liquid solution and shipped frozen on dry ice. Stability upon receipt: 1.Long-term storage: Upon receipt, store the product at −20 °C or below. When stored under the recommended conditions and maintained under sterile conditions, the product is stable for up to 3 years at -20°C under sterile conditions, not exceeding the labeled expiration date. 2.After thawing: The product may be stored at 2–8 °C for up to 6 months after the first thaw. Do not use beyond the labeled expiration date.

Please protect from light and avoid repeated freeze-thaw cycles.

Sterility

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

Endotoxin

Less than 2 EU per mL, tested by the rFC method in compliance with USP <86> and Ph. Eur. 2.6.32.

Mycoplasma

Negative

Formulation

Supplied in PBS containing EDTA, rHSA (0.1% w/v) and Poloxamer 188(0.03% w/v).

ACRO Quality Management System

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

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. GMP-certified facility (compliance with FDA cGMP, EMA GMP, ICH, ISO9001/13485/MDSAP, and certified by third-party SGS, UL, and RX360)
2. Animal origin-free materials, equipments, and facilities
3. Materials sourced only from approved suppliers
4. ISO 5 cleanrooms and automatic filling equipment
5. Professional quality personnel and training programs
6. Validated analytical testing methods in accordance with the ICH guidelines
7. Safety Testing (Sterility, Mycoplasma, etc): compliant with USP, EP, etc
8. In-depth stability studies
9. Fully batch production and control records
10. Equipment maintenance and calibration

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.