GMP Monoclonal Anti-Human CD16 Antibody (3G8)

Product Features and Advantages

1. Wide-ranging functions: Acts as a key functional reagent to support the specific activation and expansion of natural killer (NK) cells in adoptive cell therapy workflows, while enhancing antibody-dependent cellular cytotoxicity (ADCC) and effector function in CAR-NK, TIL, and NK cell cultures.
2. High Performance: Exhibits superior binding specificity to CD16 and potent biological activity, making it the preferred choice for numerous pharmaceutical enterprises in preclinical and clinical-stage NK cell therapy development and cancer immunotherapy research.
3. Comprehensive Safety Assurance: ATCC-compliant CHO host cell origin and comprehensive testing (52 items), animal origin-free (AOF) production process, with stringent final product quality control and release specifications to support clinical-grade applications.
4. Lot-to-Lot Consistency: Achieved through a stable cell line and robust manufacturing process, ensuring reliable, reproducible functional performance from early-stage research through clinical manufacturing.

GMP Platform Advantages

1. Quality Assurance: Global QMS with comprehensive and stringent QC release criteria.
2. End-to-End GMP Compliance: Full manufacturing and QC under a cGMP system.
3. Comprehensive Control of Adventitious Agents: Stringent biosafety from cell banks to final release.
4. Comprehensive Regulatory Support: Includes RSF and DMF to meet global requirements.
5. Resilient Supply Chain: Intelligent modular facilities ensure a stable global supply.
6. Professional Support: Extensive manufacturing and application expertise to accelerate development.

Source

GMP Monoclonal Anti-Human CD16 Antibody (3G8) (GMP-MC1639) is recombinantly produced from CHO cells.

Isotype

Mouse IgG1, Kappa

Specificity

This product is a specific antibody that specifically reacts with CD16/Fc gamma RIII.

Endotoxin

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

Protein A

<5 ppm of protein tested by ELISA.

Host Cell Protein

<0.5 ng/μg of protein tested by ELISA.

Host Cell DNA

<0.02 ng/μg of protein tested by qPCR.

Purity

>95% as determined by SDS-PAGE.

Sterility

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

Mycoplasma

Negative

Formulation

Supplied as 0.2 μm filtered solution in PBS, pH7.4 with protectants.

Contact us for customized product form or formulation.

Vial Specification

2R (13 mm neck finish)

Shipping

This product is supplied and shipped with dry ice, please inquire the shipping cost.

Storage

For long term storage, the product should be stored at liquid state at -70°C.

Please avoid repeated freeze-thaw cycles.

This product is stable after storage at:

1. -70°C for 5 years;
2. -20°C for 12 months under sterile conditions;
3. 2-8°C for 6 months under sterile conditions.

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.