We are pleased to announce that after obtaining DMF registration for CD3 monoclonal antibody and CD3/CD28 sorting activated magnetic beads, T&L's GMP grade products, recombinant human IL-7 protein (Cat. No. GMP-TL506) and recombinant human IL-15 protein (Cat. No. GMP-TL202), have once again obtained DMF registration from the US Food and Drug Administration (FDA) with registration numbers 038126 and 038127, respectively, which will further assist the CGT drug declaration process.

 

Recombinant human IL-7 protein


 

Recombinant human IL-15 protein


 

DMF Tip

DMF (Drug Master Files) is an archive file submitted by the holder to the drug regulatory agency (FDA) in the United States, used to provide a description of non-public information such as drug raw materials, intermediates, packaging materials, etc., usually including chemical, manufacturing and control (CMC) data, stability data, packaging material data, etc., used to verify drug quality, safety, and efficacy. DMF can be used to support new drug research applications (IND), new drug applications (NDA), simplified new drug applications (ANDA), other DMFs, or export applications.

The importance and significance of DMF filing lies in providing drug research/manufacturers with a means to prove product quality and safety to their regulatory authorities, which can greatly help them save approval costs, improve approval efficiency, and shorten drug registration cycles; At the same time, it also provides regulatory agencies with means to supervise and review drugs.

The GMP level recombinant proteins IL-7 and IL-15 of T&L have been registered with DMF after the previous registration, proving that T&L's production process and quality control system have met international standards and regulatory requirements. At the same time, it also provides more guarantees and convenience for the research and clinical application of all T&L customers.

About T&L

T&L Biotechnology Ltd is a company specializing in the research and production of upstream GMP grade raw materials and reagents for cell and gene therapy. The product involves cell sorting magnetic bead reagents, eukaryotic/prokaryotic recombinant proteins, serum-free culture media, cell culture kits, transfection reagents, gene editing tool enzymes, etc. After more than ten years of deep cultivation and sedimentation in the industry, the company has now achieved a development pattern of integrating product research and development, personalized service customization, and diversified business development, and has grown into an important supplier of domestic CGT core raw materials.

At present, the company has completed the FDA DMF filing for six products, including cell sorting magnetic bead reagents, recombinant proteins, and cell culture kits, to assist in the registration and application of CGT drugs. Please refer to the table below for details.


In the future, T&L will continue to adhere to its original intention of providing customers with higher quality and most reliable products and services, continuously optimize and upgrade product performance, strictly control GMP product release standards, meet the continuous development needs of customers, and fully support the core raw material needs of CGT drugs in the development, validation, application and other stages.

About T&L

T&L Biotechnology Ltd., founded in 2011, focuses on the research and development of upstream GMP grade raw materials and reagents of cell and gene therapy (CGT). We commit to providing reliable products and services for life science