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Chart 1: Attributes of NEBExpress Salt Active Nuclease, GMP Grade
Attributes | Values |
---|---|
Protein Purity by Microfluidic Electrophoresis | ≥ 95% |
Identification by Microfluidic Electrophoresis | Comparable to reference standard |
Nominal Protein Concentration (A280) | 1 mg/ml |
Protease activity | None detected |
Endotoxin | ≤ 5 EU/ml |
Bioburden | None Detected (Rapid) or < 5 CFU/ml TAMC, (USP<61>) < 5 CFU/ml TYMC, (USP<61>) |
Unit Activity of NEBExpress Salt Active Nuclease | 1,000,000 U/ml |
With NEB’s stringent GMP-grade manufacturing and quality control practices, NEBExpress Salt Active Nuclease, GMP Grade is suitable for host cell nucleic acid removal in development and manufacturing workflows of viral vectors, protein therapeutics and vaccines. In adeno-associated virus (AAV) bioprocessing where high salt concentration is beneficial to minimize viral particle aggregation, this enzyme enables one step host cell lysis and removal of nucleic acid impurities.
Chart 2: Manufacturing of NEBExpress Salt Active Nuclease, GMP Grade through NEB’s GMP-grade processes
NEB GMP-Grade Quality & Manufacturing for NEBExpress Salt Active Nuclease, GMP Grade | |
---|---|
Infrastructure |
Animal-free facility |
Expanded qualification/validation requirements for facilities/utilities/environment/cleaning/process equipment/computer systems | |
ISO 8 Clean Rooms and ISO 5 Filling Hoods | |
Fermentation scales ranging from 1L up to 1000L and multiple largescale downstream purification, buffer formulation and final filling suites | |
Manufacturing processes |
Beta-lactam and cephalosporin-free process and facility |
0.22 micron filtered final product |
|
Certified Animal-free origin facility and process | |
Characterized master cell bank | |
Product attributes/testing |
Enhanced panel of product contamination assays |
Validated assays with quantitative results based on relevant principles of ICH Q2 Guidelines | |
TSE/BSE statement included on Certificate of Analysis for all GMP-grade batches | |
Compendial assays, including bioburden and endotoxin levels, where applicable |
|
ICH Q1A/Q5C based product stability program | |
QA & Regulatory |
ISO 9001:2015 and ISO 13485:2016 certified QMS |
Full production batch records with defined critical quality attributes and critical process parameters | |
Regulatory supporting risk statements available, upon request, including but not limited to: melamine, residual antibiotic, mutagenic and elemental impurities, nitrosamine and residual solvents |
* “GMP Grade” and "GMP-grade" are branding terms NEB uses to describe products manufactured or finished at NEB’s Rowley facility. The Rowley facility was designed to manufacture products under more rigorous infrastructure and process controls to achieve more stringent product specifications and customer requirements. Products manufactured at NEB’s Rowley facility are manufactured in compliance with ISO 9001 and ISO 13485 quality management system standards. However, at this time, NEB does not manufacture or sell products known as Active Pharmaceutical Ingredients (APIs), nor does NEB manufacture its products in compliance with all of the Current Good Manufacturing Practice regulations.
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