Recently, the single-use multilayer co-extruded bags produced by Bio-Link have passed the DMF filing (FDA DMF filing No.: 037110) of the U.S. Food and Drug Administration, whose type belongs to the Type III DMF for drug packaging materials, covering single-use storage bags, mixing bags, cell bags and filling bags produced by Bio-Link. This means that customers who use the relevant products of Bio-Link can directly refer to the DMF filing information in the regulatory filing documents submitted to FDA for investigational new drug (IND) application, without providing specific information about raw materials and excipients. At the same time, the quality of the single-use multilayer co-extruded bags has been recognized on a global scale, serving as a milestone for Bio-Link to open up the overseas biopharmaceutical disposable consumables market.
As one of the major suppliers of key process equipment and consumables for biologics in China, Bio-Link has always been attaching great importance to building a quality management system. The company has already passed the dual quality management system certification of ''ISO9001:2015'' and ''ISO 13485:2016'', and intends to introduce quality management systems such as GMP, ISO17025 and CMA in the future, striving to develop a systematic, standardized and regulated quality system in a comprehensive manner, in an effort to become the most reliable long-term partner of domestic and foreign biopharmaceutical companies thanks to its superior-quality and high-performance products.
Significance of DMF filing
Drug Master Files (DMF) are the ones submitted to the FDA by the holder, containing confidential details of the facilities, operating procedures and raw materials in the production, operation, packaging and storage of the drug product. According to the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act), the applicant must submit relevant applications to the FDA before a drug is marketed, such as the investigational new drug (IND) application, the new drug application (NDA) and the biologics license application (BLA), and all information on safety, efficacy and quality of the drug needs to be provided, which involves the technical content of APIs and excipients. However, preparing for these materials will undoubtedly be a time-consuming, energy-intensive process, coupled with raw material suppliers' reluctance to disclose their technical information, thereby severely hampering the process of clinical application.
To address the issue, the FDA established the DMF system. Raw material suppliers can directly submit the technical content needed in the form of DMF documents to obtain record numbers, and drug applicants can directly use this number to replace the specific information about raw materials and excipients required in applications, greatly reducing the review and evaluation time.