mAb Development Platforms
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 (UBI)'s ceaseless growth and continuous sustainability to our new pipeline generation. UBI and it's subsidiary UBI Asia have spun off it's antibody based protein drug development technologies into United BioPharma(UBP). 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. UBP's cutting edge clinical research laboratories with the most advanced equipment demonstrate our incessant effort to enhance our R&D capabilities.
UBP's 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.
Protein Drug Development Technologies
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 Analysis
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.
De-fucosylation: a de-fucosylation technique to enhance ADCC activity of anti-tumor antibodies
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.
