Recently, the official website of the U.S. Food and Drug Administration (FDA for short) announced that Zhuhai Baorui Biotechnology Co., Ltd. independently developedT7 RNA polymerase, RNase RThe key enzyme raw materials for mRNA drugs have successfully passed the DMF Type II filing of the US FDA.
In the future, customers using the related products of Baorui Biotech can directly refer to the DMF filing number when submitting documents for new drug registration to the FDA, which will greatly shorten the product review and evaluation time, simplify the application process, and accelerate the project application process of related drugs.
What is "DMF"?
The Drug Master Document (DMF) is an archived document submitted to the FDA awaiting review. It contains detailed information about the production facilities, process flows, quality control, raw materials, and packaging materials used in the production, processing, packaging, and storage of drug products intended for human use.
The DMF filing in the United States is a regulation made by the FDA certification to maintain the confidentiality of information in DMF filings. Its main objective is to support FDA regulatory requirements and prove that the quality, safety and effectiveness of raw material suppliers' products have obtained the required ratings. Raw material suppliers can directly submit confidential information related to their products to the FDA without disclosing it to their customers. However, manufacturers may have to disclose certain parts of the DMF to their customers, such as product specifications and general information, as such information is essential for product development and quality control-related activities. Suppliers with a large amount of DMF are generally considered more reliable in terms of quality, regulatory status and the ability to meet cGMP requirements。
DMFFiling speeds up the process of your drug application
Usually, before a drug is launched on the market, the applicant must submit a series of applications to the FDA, such as a clinical research application (IND), a new drug registration (NDA), and a biologics license application (BLA), etc., and provide all the information about the drug in terms of safety, efficacy and quality, which involves the relevant technical content of active pharmaceutical ingredients and excipients. However, preparing these materials will undoubtedly consume a great deal of time and energy, seriously affecting the progress of the application.
The DMF filing system can solve this problem. Raw material suppliers can directly submit the required technical content to the FDA in the form of DMF documents for filing and obtain a filing number. Drug applicants can directly use the DMF filing number to replace the specific information about raw materials and excipients that needs to be provided during the filing process. This not only saves approval costs Improve the efficiency of approval to ensure that supervision and inspection can be traced. At the same time, it has greatly shortened the registration cycle, reduced repetitive research caused by differences in registration requirements, and thereby accelerated the drug application process.
The T7 promoter is the most transcriptional promoter in nature. Based on this, Baorui Biotech has successfully developed a promoter targeting T7The childThe T7 RNA polymerase, whether in terms of purityIn terms of enzyme activity, it is significantly superior to its competitors. When paired with a transcription reaction buffer that has undergone extensive process optimization, T7 RNA polymerase can precisely and efficiently identify the T7 promoter region (5'-TAATACGACTCACTATAG-3') using DNA sequences containing the T7 promoter sequence as templates. Starting from G in this region, The subsequent DNA sequence was efficiently and stably transcribed into single-stranded RNA using substrate NTPs.
Quality control
The solution is clear and transparent, with no visible foreign substances
2. Protein purity ≥95%
3. No DNase or RNase activity
4. No exonuclease or endonuclease activity
RNase R (Ribonuclease R) is a Mg2+ -dependent exonuclease derived from the RNR superfamily of Escherichia coli, which completely hydrolyzes linear RNA into dinucleotides and trinucleotides from the 3'→5' direction. It is not sensitive to circular RNA and double-stranded RNA and can be used in the production of special structure Rnas, such as circular RNA (circRNA), lasso structure RNA (lariat RNA), double-stranded RNA with a 3' protruding end of less than 7 nucleotides, and tRNA with complex structures, etc. RNase R is often used in gene expression and alternative splicing studies. It can digest linear RNA to enrich circ RNA or lariat RNA.
Quality control
The solution is clear and transparent, with no visible foreign substances
2. Protein purity ≥95%
3. No DNase activity
4. No exonuclease or endonuclease activity
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