[Blockbuster news] Tofflon cell culture-medium was approved by DMF of FDA to facilitate biological drug application Foreword

Foreword

       In October 2022, HEK293 series of chemical composition limited medium products independently developed by Shanghai Tofflon Bio-reagent Co., Ltd. were approved by the United States Food and Drug Administration (FDA) DMF II type filing (No. : 037555) acceptance letter.       This means that Tofflon HEK293 series chemical composition limited medium can help your antibody drug or macromolecular drug research project is or plans to be clinical application or new drug registration in China and the United States dual declaration.       The FDA DMF registration of the HEK293 Chemical Limited Culture provides you with the following benefits in a variety of drug applications (one or more clinical research applications (IND), innovative drug applications (NDAs), generic drug registrations (ANDAs), export applications, and amendments and supplements to each of the above applications) :

       Manufacturers of primary active substances (proteins, lentiviruses, adenoviruses, and adeno-associated viruses) or excipients only need to submit data to FDA, and do not need to give the data to the marketing applicant. This better protects the trade secrets of manufacturers of active substances (proteins, lentiviruses, adenoviruses, and adeno-associated viruses) or excipients.

       Second, the same DMF is used for different drug marketing applicants, and FDA does not need to review it multiple times, saving review resources for you.

       Thirdly, for pharmaceutical companies, by using our HEK293 series culture medium for DMF review, you can put more energy on the preparation. You can directly refer to our DMF record data when applying, which can save a lot of manpower and material resources for you, and speed up the clinical/marketing application.

1. Introduction of HEK293 series culture-medium products

        HEK293 series of medium contains HEK293 CDM15, HEK293 CDM26 and HEK293 CDM30, all of which are completely chemical-limited medium without animal origin and protein.It was suitable for large-scale serum-free suspension culture and subsequent transfection expression of HEK293 cell lines (such as HEK293F, HEK293T, HEK293H,Expi293, etc.).For protein expression, lentivirus expression, adenovirus expression, adeno-associated virus and other related product development and production process, can support cell high density amplification and stable product expression.It has a wide range of adaptability to HEK293 cell types.In order to adapt to different culture systems and production processes, complementary medium products can provide the corresponding supplement, but also can match other commercial supplement products.

2. Product advantages

● No animal source, no protein, complete chemical composition defined medium products

● Suitable for large-scale cell suspension culture with high density, strong adaptability and rich nutrition

● Suitable for bioreactor large-scale scale-up culture process, supporting batch, flow and perfusion culture mode;

● Can effectively support transfection and subsequent product expression, to ensure the stable and high quality expression of monoclonal antibody and fusion protein;

The use of high quality raw materials preparation, key raw materials using imported raw materials, high quality and stability of the product;Stable and high quality expression.

3. How to reference our DMF number?

       The full name of DMF is Drug Master Files (DMF), that is, the drug master file number, is submitted to the FDA for review, the data content contains the production facilities, production process, quality control, raw materials used in the production, processing, packaging, storage, wholesale of human drugs used in the detailed information.

       If you are using a registered HEK293 chemical-limited medium product from Shanghai Tofflon Bio-reagent Company and need to cite DMF #037555 and an official LOA authorization letter to shorten your application time and simplify the process, please contact us to make an authorization request. We will provide FDA with a DMF authorization letter after confirming your requirements.

4. Epilogue

       Tofflon Bio-reagent adhering to the mission of Tofflon people, strive to practice the substitution of biological reagents by domestic production, achieve independent research and development of key reagent products and large-scale production and supply, build an internationally leading domestic reagent brand, with professional technology to serve the biomedicine.

Introduction of Bio-reagent Company

       Shanghai Tofflon Bio-reagent Co., Ltd. is a wholly-owned subsidiary of Tofflon Science and Technology Group. Since its establishment, relying on the Tofflon systematic platform, global high-quality customer resources and professional technical support service capability, based on domestic independent research and development and open cooperation, Shanghai Tofflon Bio-reagent Co., Ltd. has established a comprehensive reagent platform integrating research and development, innovation, application transformation, production and sales of key reagents. It provides large-scale production and supply of commercial medium, customized development of personalized medium, and technical support of large-scale production process.

       In the field of macromolecular medicine (antibody/protein/vaccine), we provide culture-medium series related products for biotechnology R&D and production.In the field of cell and gene therapy, we provide serum-free medium for culture, cytokines for induction and stimulation, preservation solution for cryopreservation and other key reagents for cell and gene therapy technology (CAR T/TCR-T/NK and other immune cell and stem cell therapy technologies).

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