Medicine R&D
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.
REAGEN LLC,focusing on ELISA,PCR,Lateral Flow testing kits including clinical disease detecting kits,food&feed safety test kits and animal epidemic virus detecting kits in US for 11 years
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