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.