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

DMF

Product Show

This product can be directly isolated using conventional column-free magnetic stand (eg. Cat. MB-01/ MB-02/ MB-03/ MB-04). Please note that due to its micron-scale size, it is not compatible with commercially available column-based (M/D/L) magnetic separation systems.

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.

Mycoplasma

Negative

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).

Vial Specification

6R (20 mm neck finish)

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.