Our solid R&D and robust technology platforms are the cornerstone of our long-term business competitiveness; it’s the driving force to United BioPharma (UBP)'s ceaseless growth and continuous sustainability to our new pipeline generation. UBP has built and continues to invest in a series of well-equipped systems for cell line development, process-development, protein analysis and formulation studies. Our cutting edge clinical research laboratories with the most advanced equipment demonstrate our incessant effort to enhance our R&D capabilities.
Our integrated antibody drug development platform enable us to establish stable, high productivity, serum free clones for industrial scale production. With UBP’s innovative cell-line, process development, protein analysis and formulation methods, we are able to develop high titer, robust, scalable cell culture and establish an optimized-yield, high quality and robust monoclonal antibody drug purification process. UBP has developed more than 30 analytical development methods and validation for physiochemical and protein characterization, drug formulation development, comparability studies and quality control (QC).
UBP develops and conducts necessary biological, immunological assays for immunopharmacology research for mAb drug development.
Cell line construction for industrial use, animal cell culture process development and optimization, protein drug purification, high-concentration protein drug formulation development, viral removal validation in the purification process, animal pharmacology and a pharmacokinetic.
Protein physicochemical and biochemical characterization, protein drug quality-control system-building and validation.
Protein Drug Manufacturing
GMP cell banking, protein/mAb drug GMP manufacturing (up to 2,000 L), stability testing/quality control for active pharmaceutical ingredients and drug products, validation and quality testing of the intermediate manufacturing process.
United BioPharma's proprietary De-fucosylation technology has been established to reduce fucosylation of antibody by cellular engineering of parental CHO cells to enhance antibody-dependent cell-mediated cytotoxicity (ADCC), known to be the major mechanism or antitumor therapeutic monoclonal antibodies. This technology successfully reduces fucose attachment to Fc glycans, resulting in up to 99% of fucose-free antibody molecule in an antibody preparation.
The productivity and degree of de-fucosylation of the engineered cell lines are stable for at least 60 generations. Employing this technique, UB-923 and UB-926, a de-fucosylated rituximab and a de-fucosylated trastuzumab, respectively, were developed. Both de-fucosylated antibodies enhance their ADCC activities by at least ten fold without altering their CDC activities.
The de-fucosylation technology can be applied to enhance the ADCC activity of therapeutic antibodies that are to be used in the hematology and oncology fields.