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YEASEN 8 core enzymes obtained DMF filing

Following UltraNuclease's DMF filing, YEASEN has obtained DMFs of 8 core enzymes from the US FDA.

The filing number is:

Figure 1. FDA

Number Product Name Filing Number
1 UltraNuclease MF037298
2 T7 RNA Polymerase MF037035
3 T7 RNA Polymerase GMP-grade MF037035
4 mRNA Vaccinia Capping Enzyme GMP-grade MF037433
5 mRNA Cap 2'-O-Methyltransferase GMP-grade MF037434
6 Pyrophosphatase,Inorganic GMP-grade MF037545
7 Murine RNase inhibitor GMP-grade MF037546
8 BspQI GMP-grade MF037607

 

1. What is DMF?

The DMF (Drug Master File) is an archived document submitted by DMF holder to the Food & Drug Administration. The content contains detailed information about the production facilities, technological processes, quality control, raw materials, and packaging materials used in the production, processing, packaging, and storage of pharmaceutical products for the human body. There are five types of DMFs:

Type Range
Type I  Manufacturing site, Facilities, working procedures, personnel (now cancelled)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparatio
Type V FDA-Accepted Reference Information

 

2. Purpose of DMF filing

2.1 Ensure product compliance

FDA has the authority to file DMF submissions. When reviewing a user's drug application, FDA can conduct a comprehensive examination of the DMFS involved through the certificate of authorization provided by the DMF holder. In addition, the DMF archived in the FDA Central Document Room (CDR) can support all users of the product. The DMF holder does not need to provide data to each user repeatedly, controlling the transmission of product data and improving confidentiality.

2.2 Shorten the registration period

The DMF as reference data in the CDR and can be used for one or more clinical investigational applications (IND), innovative drug applications (NDAs), simplified New drug applications (ANDAs), export applications, and amendments and supplements to each of these applications.
If an API wants to enter the US market and obtain FDA approval, it needs to obtain the DMF registration number. When the drug manufacturer submits the registration application data to FDA, the DMF file registration number of the API can be directly quoted in the API part's data, so that the FDA can quickly obtain the specific information about the raw materials. This can not only save the approval cost but also improve the approval efficiency and reduce the repetitive research caused by the differences in registration requirements.

 

3. Product Introduction

3.1 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).

3.2 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.

3.3 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.

3.4 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.

3.5 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.

 

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
UCF.ME®UltraNuclease GMP-grade 20157ES 25KU/50KU/100KU/1MU/5MU
T7 RNA Polymerase GMP-grade (50 U/μL) 10624ES 5000U/50000U
T7 RNA Polymerase GMP-grade (250 U/μL) 10625ES 10KU/100KU/2500KU/100MU
mRNA Vaccinia Capping Enzyme GMP-grade (10 U/μL) 10614ES 2KU/10KU/100KU/5MU
mRNA Cap 2´-O-Methyltransferase GMP-grade (50 U/μL) 10612ES 10000U/50000U/250000U/20MU
Pyrophosphatase, Inorganic GMP-grade (1 U/μL) 10620ES 10U/100U/1000U/40KU
Murine RNase inhibitor GMP-grade (40 U/μL) 10621ES 10KU/20KU/100KU/1MU
BspQI GMP-grade (10 U/μL) 10664ES 500U/2500U/10KU/100 KU
Deoxyribonuclease I (DNase I) GMP-grade (2 U/μL) 10611ES 500 U/2000U/10000U