• Medicine R&D

    Medicine R&D

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  • 1. Antibody drugs

    1) service characteristics

    * mammalian cells are highly effective in expressing antibody drugs, CHO-K1 cell lines, with clear source.

    *Independent research and development of the expression vector, no intellectual property rights problems.

    *By optimizing the composition of basic medium and feeding medium, the expression of antibody in high density cell culture (200L disposable reactor) can reach 2-5g/L, the batch yield can reach 300-800g, and the passage of MCB/WCB 90 PDL is stable.

    *Technical team members have extensive experience in the construction and process development of CHO stable transfection cell lines with multiple antibody drugs, and more than a dozen practical projects in FDA IND registration applications.

    2) service content

    *Construction and screening of antibody stable expression cell line (RCB).

    *Preparation and verification of GMP three level cell bank.

    *High density cell culture technology development and antibody purification process development.

    *The development and complete methodology validation of antibody raw liquor and finished product quality inspection methods.

    *Study on formulation and technology of antibody preparation (excipient screening, packaging  

    material screening, compatibility study).

    *Process enlargement and GMP pilot production.

    *Stability study

     

    3) deliverables: declaration materials that meet the requirements of FDA.

    2. recombinant protein drug 

    1) service characteristics

    *Provide technical services for high-level expression of recombinant proteins in E.coli engineering bacteria, including inclusion body expression, soluble expression and secretory expression, in which soluble protein expression can reach 2-8 g/L. By optimizing the proportion of basic medium and feeding medium and using pure oxygen, the wet cell of E. coli engineering bacteria fermentation (50L/500L) could reach 200g/L.

    *The recombinant protein was expressed efficiently in Pichia pastoris, and the expressed protein could reach 2-4g/L. Fermentation of Pichia pastoris Engineering (50L/500L) could reach more than 300g/L.

    *Technical team members have many years of microbial engineering bacterial fermentation experience, successfully completed a number of interferon, cytokines, peptides CDMO research and development technology services projects, customers have submitted IND applications, through on-site verification.

    2) service contents:

    *Preparation and verification of GMP three class seed bank.

    *Development of high density fermentation technology for microorganism engineering and purification of recombinant protein.

    *(DS) and the finished product (DP) quality test method development and complete methodology validation.

    *Preparation of formulation and Technology (excipient screening, packaging material screening, compatibility study).

    *Process enlargement and GMP pilot production.

    *Preparation and characterization of reference products.

    *Stability study

    3) deliverables: declaration materials that meet the requirements of FDA.


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    About Us

    REAGEN LLC,focusing on ELISA kits including clinical disease detecting kits,food&feed safety test kits and animal epidemic virus detecting kits in US for 6 years

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    • 102 Commerce Dr.Unit 8,     
               Moorestown,NJ,08057 USA
    • 619-389-8888
    • reagenkits@gmail.com
    • www.reagen.us