GMP Salt Active GENIUS™Nuclease

DMF

GMP平台优势（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.

产品描述（Product Details）

GMP Salt Active GENIUS™Nuclease is developed with ACRObiosystems' unique enzyme AI evolution platform based on wild-type Serratia marcescens endonuclease. It is capable of maintaining high specific activity to effectively degrade nucleic acids in any form across a broad salt concentration range (0-500 mM NaCl), especially high salt up to 500mM NaCl, which makes it suitable for nucleic acid removal in processes that of higher salt conditions. The enzyme is a non-specific nuclease with high specific activity, degrading single- and double-stranded nucleic acids in any form (single stranded, double stranded, linear, circular, and supercoiled). It hydrolyzes internal phosphodiester bonds present between the nucleotides to 5’- phosphorylated oligonucleotides of 3-5 bases in length.

应用说明（Application）

Elimination of nucleic acids from biologics, suitable for samples with 0-500 mM salt in presence of 5-10 mM Mg++

• clinical viral vaccine production

• clinical viral vector production for cell and gene therapy (CGT)

• Other clinical development and production uses

纯度（Purity）

>95% as determined by SDS-PAGE.

>95% as determined by SEC-HPLC.

酶活（Enzyme Activity）

＞250 U/μL

宿主蛋白残留（Host Cell Protein）

<0.05 ng/µg of protein tested by ELISA.

蛋白酶活性（Protease Activity）

Negative

无菌（Sterility）

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

支原体（Mycoplasma）

Negative

内毒素（Endotoxin）

Less than 10 EU/mg, tested by the LAL method in compliance with USP <85> and Ph. Eur. 2.6.14.

制剂（Formulation）

Supplied as 0.2 μm filtered solution in 25 mM Tris, 500 mM NaCl, 5 mM MgCl2, pH7.5.

Contact us for customized product form or formulation.

西林瓶规格（Vial Specification）

2R (13 mm neck finish)

运输（Shipping）

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

存储（Storage）

This product is stable after storage at:

1. The product MUST be stored at -20°C or lower upon receipt;
2. -20°C for 5 years under sterile conditions.

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