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Five mRNA core enzymes completed DMF filing

Yeasen mRNA synthesis-related core enzymes have recently received confirmation letters from the U.S. Food and Drug Administration(FDA). Following the filing of T7 RNA Polymerase, Yeasen has received DMF data on six products from the U.S. FDA. The ICP Filing Number is :

Figure 1. FDA

Number

Product Name

Application Number

1

T7 RNA Polymerase GMP-grade

MF037035

2

mRNA Vaccinia Capping Enzyme GMP-grade

MF037433

3

mRNA Cap 2'-O-Methyltransferase GMP-grade

MF037434

4

Pyrophosphatase,Inorganic GMP-grade

MF037545

5

Murine RNase inhibitor GMP-grade

MF037546

6

BspQI GMP-grade

MF037607

 

1. Purpose of DMF filing

DMF (Drug Master File) is a file submitted to the FDA by DMF holders, which contains detailed information about the production facilities, processes, quality control, and raw materials and packaging materials used in the production, processing, packaging, and storage of drug products for human use. DMF holders only need to provide the user with a power of attorney authorizing the FDA to conduct a thorough review of the DMF involved when reviewing the user's drug application. Such a DMF system allows drug declarants to directly use DMF filing numbers instead of specific information about raw materials and excipients that need to be provided during the declaration process, saving approval costs, improving approval efficiency and shortening the registration cycle.

 

2. Filed Product Introduction

2.1 Vaccinia Capping Enzyme

Vaccinia capping enzyme is an effective enzyme that catalyzes the formation of the cap structure of RNA, which consists of two subunits, D1 and D12, and has both RNA triphosphates activity, guanylyltransferase activity, and guanine methyl transferase activity, which can attach the 7-methylguanine cap structure (m7Gppp) to the 5 ' end of RNA (m7Gppp5'N).

2.2 Cap 2'-O-Methyltransferase

Dioxymethyltransferase can add a methyl group of the 5 ends of RNA immediately next to the 2 - O position of the first nucleotide of the cap structure, and use SAM as a methyl donor to methylate the cap RNA, thereby forming a Cap1 structure and enhancing the translation efficiency of mRNA.

2.3 Pyrophosphatase, Inorganic

Inorganic pyrophosphate is an enzyme that catalyzes the conversion of one molecule of pyrophosphate into two molecules of phosphate ions. This is a high energy release reaction, so this reaction can be coupled to some thermodynamically unfavorable transformations to drive these transformations to complete. Inorganic pyrophosphates (PPase ) catalyze the hydrolysis of inorganic pyrophosphate to orthophosphate, which can be used to increase RNA yield in reverse transcription reactions.

2.4 Murine RNase inhibitor

RNase inhibitors can bind to RNases to form complexes, thereby specifically inactivating RNases and widely inhibiting various types of RNases (RNase A, B, C ) . And by RT-PCR, RT-qPCR tests / tested. Compared with human RNase inhibitors, this product does not contain two cysteines in human proteins that are very sensitive to oxidation, so it has higher antioxidant activity. At the same time, it is more suitable for sensitive experiments with high DTT.

2.5 BspQ I 

BspQI is a restriction enzyme type II with a recognition sequence of 5'-GCTCTTCN1/N4-3 ', which is mainly used to digest plasmids to prepare linearized DNA fragments of the end of poly (A/T/G/C ) to obtain specific sticky ends.

 

3. Product application

3.1 In Vitro Transcription (IVT)

Figure 2. In Vitro Transcription (IVT)

3.2 mRNA capping Reaction

Figure 3. mRNA capping Reaction

 

4. Product advantages

▪ Complies with ISO 13485 system
▪ Comply with GMP requirements
▪ No antibiotics, no animal origin
▪ Mass production.
▪ General file support
▪ Pass stability check

 

5. Products information

The products information is as follows:

Product Name

Cat#

Size

T7 RNA Polymerase GMP-grade (50 U/μL)

10624ES

5000 U/50000 U

T7 RNA Polymerase GMP-grade (250 U/μL)

10625ES

10KU/100 KU/2500 KU/100 MU

mRNA Vaccinia Capping Enzyme GMP-grade (10 U/μL)

10614ES

2 KU/10 KU/100 KU/5 MU

mRNA Cap 2´-O-Methyltransferase GMP-grade (50 U/μL)

10612ES

10000 U/50000 U/250000 U/20 MU

Pyrophosphatase, Inorganic GMP-grade (1 U/μL)

10620ES

10 U/100 U/1000 U/40 KU

Murine RNase inhibitor GMP-grade (40 U/μL)

10621ES

10 KU/20 KU/100 KU/1 MU

BspQI GMP-grade (10 U/μL)

10664ES

500 U/2500 U/10 KU/100 KU

C152P1 BspQI (200 U/μL) (Inquire)

16215ES

5000 U/250 KU/1 MU