Recently, T&L Biotechnology Ltd. (referred to as "T&L") successfully obtained the US FDA DMF registration for its CGT core raw material CD28 monoclonal antibody, with DMF registration number 038820.

Your cell therapy research project can directly reference the DMF filing number in the clinical application or new drug registration documents, greatly reducing the communication, review, and evaluation time for application and simplifying the IND application process.


T&L helps CGT drugs set sail!

T&L has comprehensively laid out production lines for CGT important core raw materials such as cell sorting reagents, recombinant proteins, and immune cell culture media，it has achieved a diversified development pattern of product research and development, personalized service customization, and business development, and is committed to becoming a professional brand in the field of CGT core raw materials.

At present, the company's GMP level CD3 monoclonal antibodies, CD28 monoclonal antibodies, and ActSep ® The CD3/CD28 sorting activation magnetic beads, IL-7, IL-15, NK, and MSC cell culture test kits have all completed the US FDA DMF filing, which also proves that T&L's production process and quality control system have met international standards and regulatory requirements, providing more guarantees and convenience for customer research and clinical application, and accelerating CGT drug application.


If you have used products registered with T&L DMF and need to reference the DMF number, please send an email to huodong@seafrom.cn or contact your account manager to apply for authorization, and we will assist your company in clinical application or new drug registration.

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