【Blockbuster】T&L CGT core raw materials have been re-registered with the US FDA DMFNew Blog Post
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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
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