Reagents and Complete Solutions for mRNA-based Drug Development
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Reagents and Complete Solutions for mRNA-based Drug Development

Company Overview Founded in 2014, Yeasen Biotechnology Co.,Ltd is a high-tech enterprise committed to the development and production of enzymes and antibodies for the life science industry. Products supplied by Yeasen include molecular diagnostic enzymes, proteins and antibodies applicated in the industry of medicine, food safety testing, breeding and judicature. Yeasen is dedicated to providing our customers with high-quality products and services.

Contents Yeasen Provides GMP-grade Reagents Why to Choose GMP-grade Raw Materials? Yeasen Acquired DMF Numbers for Many Products The mRNAtools Facility Workflow & Reagents Template Generation In Vitro Transcription mRNA Capping mRNA Purification Ordering Information References

Yeasen Provides GMP-grade Reagents Yeasen is the first company receiving the ISO 13485 Yeasen has successfully achieved the ISO 13485 and distribution of molecular enzymes in China. every year. “GMP-grade” is a branding term that certification and we undergo a successful inspection certificate for research, development, manufacture Yeasen uses to describe reagents manufactured at “ISO” stands for International Organization for ISO 13485 certified facilities. Yeasen’ GMP-grade s Standardization. “13485” refers to the specific reagents are produced in compliance with ISO 13485 certification for...

Why to Choose GMP-grade Raw Materials? Quality Controls Animal-derived material may be used (Animal-free certificates can be provided if required) Cell bank characterization Less stringent Stringent （compliant with GMP regulations） Traceability information for raw materials and finished product Less stringent Stringent （compliant with GMP regulations） Endotoxin level control Sterile control Batch records for manufacturing and testing Less stringent Process validation report Change control system Stringent （compliant with GMP regulations） Quality management system Stringent Stringent Stringent...

Yeasen Acquired DMF Numbers for Many Products Drug master files (DMFs) are documents submitted voluntarily to the US Food & Drug Administration (FDA) that contain confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. The FDA reviews the technical contents of a DMF when an API manufacturer incorporates it as a reference to support its Investigational New Drug Application (IND), New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), and Export Application. DMFs have...

Based on wide experience and technical advantages in the enzyme development and industrial production, Yeasen constructed a new facility, named as “mRNAtools”to supply raw materials for mRNA-based drugs. Cover, ing 50000 square feet, the mRNAtools facility is built and operated in accordance with GMP regulations and is equipped with 2×1500L automatic fermentation equipment, industrial-scale purification and lyophilization equipment. Up to now, the mRNAtools facility has been applied to the production of raw materials required in the manufacture of mRNA-based drugs. These raw materials are...

Workflow & Reagents Plasmid Linearization ● Template Generation BspQI BsaI T7 High Yield RNA Synthesis Kit T7 RNA Polymerase Pyrophosphatase, Inorganic Vaccinia Capping Enzyme mRNA Modification Poly(A) Tailing Poly(A) Polymerase mRNA Purification mRNA Isolation Master Kit RNA Cleaner Magnetic Separation Rack Natural and Modified Nucleoside Triphosphates GMP Murine RNase Inhibitor

Template Generation Plasmid linearization is an indispensable step during template generation when plasmid vectors are used as transcription templates. As transcription proceeds to the end of DNA templates, plasmid linearization ensures that RNA transcripts of a defined length and sequence are generated. Yeasen provides various restriction enzymes to meet your needs. We recommend selecting restriction enzymes that generate blunt ends or 5´-overhangs. High Purity High Specific Activity Example: Restriction digestion A*company ____________ M 0.125 U 0.5 U 2 U Figure1. The performance of Yeasen...

T7 RNA Polymerase is a DNA-dependent RNA polymerase that is highly specific for the T7 phage promoters. In cell-free system with DNA templates and NTPs, T7 RNA Polymerase catalyzes in vitro transcription from a cloned DNA sequence under the T7 promoters to synthesis RNAs. T7 High Yield RNA Synthesis Kit Murine RNase Inhibitor High Yield High Integrity Example 1： Standard RNA synthesis A Final Concentration Figure 1. High yield can be achieved by Yeasen standard RNA synthesis reaction. A 20 μL IVT reaction for standard RNA synthesis was set up according to the table (A) and incubated at 37°C...

Example 2： Capped RNA synthesis with modified nucleotides and cap analogs A 20 μL Reaction Final Concentration 2 μL Yield (mg/mL) Pyrophosphatase, Inorganic Murine RNase Inhibitor Capped RNAs Figure 2. High yield and high integrity can be achieved by Yeasen capped RNA synthesis reaction. A 20 μL IVT reaction for capped RNA synthesis was set up according to the table (A) and incubated at 37°C for 2 hours in a PCR machine. Transcripts were purified by magnetic beads RNA Cleaner, Yeasen#12602) and quantified by NanoDrop® spectrophotometer (B). The length and integrity of （ transcripts was...

mRNA Capping As 5´ cap structure reduces immunogenicity and is required for efficient translation of mRNAs, adding cap struc- tures to the 5′ end of mRNA generated by in vitro transcription is necessary. Capping Strategies Post-transcriptional Capping 5’ 3’ Vaccinia Capping Enzyme +SAM +SAM Co-transcriptional Capping Vaccinia Capping Enzyme 2'-O-Methyltransferase High Purity

Example 1： Post-transcriptional Capping A Final Concentration Murine RNase Inhibitor Vaccinia Capping Enzyme RNase-free H 2 O Figure 1. The capping efficiency of Yeasen post-transcriptional capping reaction could be close to 99%. 10 μg RNAs were denatured by incubation at 65°C for 5 min before capping. A 20 μL post-transcriptional capping reaction was set up according to the table (A) and incubated at 37°C for 2 hours in a PCR machine. Transcripts were purified by magnetic beads (RNA Cleaner, Yeasen#12602). Then the capping efficiency is detected by LC-MS (B). Example 2： Co-transcriptional...