The year 2021 will stand out as a year of milestones for Vazyme. In mid-November, we have witnessed Vazyme’s successful listing on the SSE Star Market after a decade of hard work. At the end of the year, triumphant news keeps pouring in. Vazyme has received a great gift from the FDA — Vazyme UniversalBenzoNuclease has officially obtained FDA preclearance for the type II DMF (number: 036580), which means it meets the requirements of the U.S. market access.
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
According to the US Federal Food, Drug and Cosmetic Act (FDCA), before a drug can be marketed, the applicant must submit relevant applications to the FDA, such as Investigational New Drug Application (INDs), New Drug Application (NDAs) and Biological License Applications (BLAs). Beside, information on the drug safety, efficacy and quality is also needed, which involves the technical content of active pharmaceutical ingredients (APIs) and excipients. However, the preparation of these materials costs a lot of time and effort, and raw material suppliers are also reluctant to disclose their technical information, resulting in delays in the clinical application.
To solve this problem, the FDA established a DMF system, allowing raw material suppliers to submit DMF documents in the form of the required technical content directly to the FDA and obtain registration number For the preparation clinical/marketing applicants, they can use raw materials approved by the DMF, then focusing more on the preparation. By directly using references to DMF records of raw materials when submitting, they can save a lot of human and material resources to speed up the clinical/marketing approval.
Due to the rapid advances in biotechnology in China, an increasing number of mammalian cells, especially continuous cell lines, are used for the production of vaccines and therapeutic biological products, attracting more attentions from the drug regulatory authorities to the safety of vaccines and other biologics. The detection of nucleic acid residues in cells is a key item, especially DNA, which is stable and easy to remain during the production of biologics, and these residues can be extremely harmful to the human body. Thus, removing residual nucleic acid is an essential part of the biologics production.
Removing residual nucleic acid for large-scale production of biologics
✦ Using column chromatography and tangential flow filtration to effectively remove Benzonase Nuclease, without any labels.
✦ Large capacity, single-line production,long route of controlled process, and stable intra-batch and inter-batch production quality.
✦ Under CHQ7 guidelines, the production, quality control and supporting documentation system are submitted to the DMF, which meet the requirements of the R&D and production of biologics.
✦ Available supporting enzyme residue test kits with good stability, which can match most nucleases on the market.