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GMP-GRADE REAGENTS for RNA SYNTHESIS Below Highlights Our Capabilities for Both Research-Grade and GMP-Grade Materials

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GMP-GRADE REAGENTS for RNA SYNTHESIS Below Highlights Our Capabilities for Both Research-Grade and GMP-Grade Materials USA NOT SURE WHETHER YOU NEED RESEARCH- New England Biolabs, Inc. Telephone (978) 927-5054 Toll Free (USA Orders) 1-800-632-5227 GRADE OR GMP-GRADE MATERIALS? Toll Free (USA Tech) 1-800-632-7799 Fax (978) 921-1350 [email protected] We are happy to work with you to assess your needs to help identify which solution will work best www.neb.com for you. Our research-grade reagents produced under ISO13485 & 9001 controls are highly pure Australia & New Zealand and undergo stringent quality controls, and, in many cases, will satisfy your needs. The table New England Biolabs (Australia) PTY GMP-GRADE REAGENTS FOR RNA SYNTHESIS below highlights our capabilities for both research-grade and GMP-grade materials. Telephone: 1800 934 218 (AU) [email protected] Telephone: 0800 437 209 (NZ) TOOLS TO TAKE YOU FROM TEMPLATE TO TRANSCRIPT [email protected] Canada New England Biolabs, Ltd. Toll Free: 1-800-387-1095 [email protected] China New England Biolabs (Beijing), Ltd. Telephone: 010-82378265/82378266 [email protected] France RESEARCH GRADE (IPSWICH, MA, USA) GMP GRADE (ROWLEY, MA, USA) New England Biolabs France MANUFACTURING • Animal-derived material may be used during manufacturing or • Manufacturing process and final formulation is animal-free Telephone: 0800 100 632 PROCESSES in final formulation (e.g., BSA) [email protected] • Fully characterized cell banks, dedicated chromatography • Can remove animal-derived material, if needed resins, filtration into sterile containers Germany & Austria • Manufacturing process may evolve as requirements to scale • Strict change control system reduces risk and ensures New England Biolabs GmbH change; products subject to contractual change control additional transparency Free Call: 0800/246 5227 (Germany) provisions Free Call: 00800/246 52277 (Austria) [email protected] PRODUCT ATTRIBUTES • Traceability information available for raw materials and finished • TSE/BSE statements for all products; animal-free raw product, upon request materials, processes and formulation Japan New England Biolabs Japan, Inc. • Extensive specifications applied to all products, including • Compendial assays applied to all products, including bioburden Telephone: +81 (0)3 5669 6191 custom specifications, upon request and endotoxin levels [email protected] • Stringent assays performed on all products, with pass/fail • Qualified assays for all products, including E.coli gDNA and criteria provided other contamination assays (quantitative result) Singapore New England Biolabs, PTE. Ltd. QA & REGULATORY • ISO 9001 and ISO 13485 certification • ISO 9001 and ISO 13485 certification Telephone +65 638 59623 • Robust manufacturing records across all products • Batch history files/batch records and defined CQAs and CPPs [email protected] • Change management and lot disposition processes in place • Enhanced change management and lot disposition processes United Kingdom in place New England Biolabs (UK), Ltd. Call Free: 0800 318486 [email protected] Comparability analyses of research- Research-grade IVT reagents GMP-grade IVT reagents ISO 9001 ISO 14001 ISO 13485 grade and GMP-grade IVT reagents Registered Registered Registered Quality Environmental Medical Devices Management Management DNA template encoding green Cap1 mRNA with Vaccinia fluorescent protein (GFP) Capping Enzyme and 2´-O Methyltransferase One or more of these products are covered by patents, trademarks and/ or copyrights owned or controlled by New England Biolabs, Inc. For more In vitro transcription of GFP information, please email us at [email protected]. The use of these products RNA purification with may require you to obtain additional third party intellectual property rights for with T7 RNA Polymerase certain applications. Monarch RNA Cleanup Kit Your purchase, acceptance, and/or payment of and for NEB’s products is pursuant to NEB’s Terms of Sale at www.neb.com/support/terms-of-sale. NEB does not agree to and is not bound by any other terms or conditions, unless those terms and conditions have been expressly agreed to in writing RNA purification with by a duly authorized officer of NEB. ® Monarch RNA Cleanup Kit Expression in HEK 293 cells Functional expression of active green fluorescent protein in HEK 293 cells after transfection of capped poly-adenylated mRNA demonstrates qualitative equivalence of GMP-grade and research-grade reagents. GMP_RNA – Version 3.0 – 05/21 For over 45 years, NEB® has been a world leader in the discovery and production of reagents for the life science industry. Our enzymology expertise effectively positions us BENEFITS OF GMP-GRADE mRNA SYNTHESIS WORKFLOW EXAMPLE to supply reagents for the synthesis of high-quality RNA – from template generation and transcription, to capping, tailing and cleanup after synthesis. These products are designed MANUFACTURING AT NEB & AVAILABLE NEB PRODUCTS and manufactured based on decades of molecular biology experience, so that you can NEB’s expertise in enzyme manufacturing positions us to best anticipate TEMPLATE IN VITRO RNA POLY(A) RNA be confident they will work for your application. GENERATION TRANSCRIPTION CAPPING TAILING PURIFICATION your needs and minimize the risk of transferring manufacture of your materials to our GMP-grade production facility. Examples of customer Q5® High-Fidelity DNA Monarch® RNA HiScribe™ T7 ARCA mRNA Synthesis Kit (with tailing) To better serve the needs of customers in regulated markets, NEB has opened requirements that are achieved by our GMP-grade reagents include: Polymerase Cleanup Kit (10 µg) E. coli Poly(A) Monarch RNA a state-of-the-art, 43,000 sq. ft. production facility in Rowley, MA for the • Bioburden and/or endotoxin specifications on reagents dNTP solution mixes HiScribe T7 ARCA mRNA Synthesis Kit Polymerase Cleanup Kit (50 µg) manufacture of GMP-grade* materials – approximately 15 minutes from our • Certified animal-free origin and manufacturing process HiScribe T7 main campus in Ipswich, MA, USA. This purpose-built facility includes Vaccinia Monarch RNA • Qualified equipment, utilities, QC test methods and instrumentation BspQI* High Yield RNA COMING Capping System Cleanup Kit (500 µg) Quality Control and Production functions ranging from a to deliver the highest levels of lot-to-lot consistency SOON Synthesis Components shipping/receiving area and dedicated warehouse, HiScribe T7 Quick High mRNA Cap DNA Assembly Lithium Chloride to separate inoculation preparation, Yield RNA Synthesis Kit 2´-O-Methyltranferase Infrastructure & Approach • NEBuilder HiFi DNA fermentation, purification and Assembly HiScribe SP6 High Yield ARCA and other • Golden Gate Assembly RNA Synthesis Kit mRNA cap analogs filling suites. • Purpose-built for GMP-grade manufacturing • Increased manufacturing output T3 & SP6 RNA Polymerases • ISO 8 clean rooms, ISO 5 filling hoods T7 RNA Polymerase • Environmental monitoring of the facility Hi-T7 RNA Polymerase • Animal-free facility Companion Products Companion Products RNase inhibitor Monarch RNA Cleanup Manufacturing Processes (Murine) Binding Buffer RNase Inhibitor Monarch RNA Cleanup • Lateral transfer from Ipswich to Rowley (Human Placental) Wash Buffer • Characterized master cell banks Pyrophosphatase, Nuclease-free Water • Ampicillin-free processes Inorganic (E. coli) • Dedicated chromatography resins Pyrophosphatase, Inorganic (Yeast) • 0.22 micron-filtered final product DNase I (RNase-free) Product Attributes/Testing NTPs • TSE/BSE statements – animal-free raw materials, processes and = available in GMP-grade * NEB can offer large-scale preparations of restriction enzymes using Recombinant Albumin (BSA-free) formulation • Bioburden and endotoxin included for all products, with numerical values provided ENABLING GRAM-SCALE • Appearance, protein concentration, gDNA contamination and other current QCs qualified From research to therapeutic production, NEB’s RNA SYNTHESIS • Stability testing program in vitro transcription portfolio will meet your needs. • Contamination and other current QCs qualified NEB manufactures and inventories the following enzyme specificities at GMP-grade, NEB’s portfolio of research-grade and GMP-grade reagents support microgram scale research production to meeting customer needs with short lead times: ™ QA & Regulatory gram scale therapeutic mRNA production. Our optimized HiScribe kits enable convenient in vitro transcription • Vaccinia Capping Enzyme • T7 RNA Polymerase • mRNA Cap (IVT) workflows. When it is time to scale up and optimize reaction components, our standalone reagents are 2´-O-Methyltransferase • RNase Inhibitor, Murine • Pyrophosphatase, Inorganic • ISO 9001 and ISO 13485 certification readily available in formats matching our GMP-grade offering, enabling a seamless transition to large-scale (E. coli) • DNase I (RNase-free) • Batch history files/batch records therapeutic manufacturing. • Defined CQAs and CPPs To inquire about custom formats, or GMP-grade reagent production, • Enhanced change management and lot disposition processes Learn more at * “GMP-grade” is a branding term NEB uses to describe reagents manufactured at our Rowley, MA facility, where we utilize procedures and process controls to manufacture reagents under more rigorous condi- tions to achieve more stringent product specifications, and in compliance with ISO 9001 and ISO 13485 quality management system standards. NEB does not manufacture or sell products known as Active • Customer support for regulatory submissions contact us at Pharmaceutical Ingredients (APIs), nor do we manufacture products in compliance with all of the Current Good Manufacturing Practice regulations. www.neb.com/GMP [email protected].
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