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Recently, Hzymes Biotechnology Co., Ltd.((hereinafter referred to as Hzymes Biotech) received a confirmation letter from the US Food and Drug Administration (FDA). The FDA said that it has completed the DMF filing of six products, including the core enzymes for the in vitro synthesis of mRNA, and the UltraNuclease. The specific product list is as follows:
DMF, or Drug Master Files, is an archived material submitted to the FDA for review, including details of the production facilities, processes, quality control, and raw materials used in manufacturing, processing, packaging, storage, and wholesale of pharmaceutical products for human use.
The U.S. Federal Food, Drug, and Cosmetics Act stipulate that before a drug is listed, the declarant must submit a series of applications to the FDA, such as a clinical research application (IND), a new drug registration (NDA), and a biological product license application (BLA), and needs to provide all the information on the safety, efficacy, and quality of the drug, which involves the relevant technical content of APIs and excipients, but the preparation of these materials will undoubtedly consume a lot of time and effort, so it will seriously affect the process of clinical declaration.
In order to solve this problem, the FDA established and implemented the DMF system in 1989, the raw material supplier in the form of DMF documents to the FDA for the record and obtain the filing number, the drug declarant can directly use the DMF filing number to replace the specific information of raw materials and excipients that need to be provided in the declaration process, greatly shortening the review and evaluation time. Raw material suppliers, on the other hand, can submit confidential product-related information directly to the FDA without disclosing it to their customers. This protects their intellectual property from infringement while complying with regulatory requirements for disclosing product details. They are still required 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. The main objective of the DMF is to support FDA regulatory requirements and to demonstrate that the quality, safety, and effectiveness of raw material suppliers have received the required ratings. Suppliers with a large number of DMFs are generally considered more reliable in terms of quality, regulatory standing, and ability to meet CGMP (Current Good Manufacturer Processes).
Introduction of Hzymes Biotech products that have completed DMF filing:
UltraNuclease (GMP Class): The preferred nucleic acid remover in the biopharmaceutical industry.
No animal origin: In line with the requirements of the Chinese pharmacopeia for the safety control of biological product viruses
Strict quality control: HCP, microorganisms, endotoxins, and metal ion residues are low and have high batch-to-batch consistency.
Good stability: Superior thermal stability.
Worry-free to use: Supplied with a high-sensitivity detection kit to quantitatively detect residues.
High sensitivity: Minimum quantitation limit as low as 0.02 ng/mL, detection limit < 0.01 ng/mL.
Good precision: CV in the batch< 10%, CV between the batch<10%.
Easy to operate: The coated plate is ready to use, and the reaction time is shortened by 0.5-1 hour.
GMP grade mRNA series enzymes
As the original enterprise of biopharmaceutical raw materials with the company’s vision of “becoming a world-class supplier of core enzyme raw materials products and services”, Hzymes Biotech has always taken the global supply of biomedical core raw materials as a responsibility, so that “each molecule promise accuracy” has become a Hzymes oath that resounds around the world!
+86-15821125706 info@hzymes.com Marketing Center NO. 1588, Huhang Road, Office 701, Shanghai , Shanghai CN
