Founded in Boston in 2014, BiBo Pharma has been operating in China since 2017, with production capacity to be established in 2019, BiBo Pharma’s full-spectrum platform of microbial fermentation, mammalian cell culture, ADC and GCT has the ability to provide one-stop service from R&D to ultra-large-scale commercial production.
We offer full life-cycle services from consulting, cell line/strain development, upstream cell culture/ fermentation development, downstream purification development, analytical development, formulation development, process characterization, technology transfer, non-GMP tox material supplies, and GMP production of DS and DP (50L/200L/500L/2000L/3000L/10000L/30000L scale).
Both our R&D centers (Shanghai & Boston) upstream capacities range from high-throughput milliliter-scale micro-bioreactors to 50L pilot-scale bioreactors. We also have 1-L Eppendorf DasGIP parallel bioreactors, 5-L, and 15L benchtop bioreactors.
For our downstream capacities, we have AKTA Purifier 10, AKTA Explorer 100, and pilot-scale 6mm Skid Bioprocessor that can handle up to 200L/hr purification.
Yes, BiBo Pharma provides scale-down model development and qualification.
BiBo Pharma team has extensive experience with tech transfer, scale-up and scale-down process development. In our R&D center, we have 1L, 5L, and 15L benchtop bioreactors as well as 50L pilot-scale bioreactor. For downstream, we have AKTA Purifier 10, AKTA Explorer 100, and pilot-scale 6mm Skid Bioprocessor that can handle up to 200L/hr purification. In our GMP facilities, we have 50L, 200L, 500L, 2000L , 3000L, 10000L and 30000L bioreactors. For downstream, we have We have a wide range of chromatography systems, with the largest columns up to 2 meters in diameter, which can support our clients from pilot to ultra-large scale production of biopharmaceutical drug substance. We offer liquid vial, lyophilized and pre-filled syringes as well as drug-device combination product filling and finishing service.
The documentation quality in BiBo is top-rated to support GMP tech transfer and manufacturing.
We work with different types of bacteria and yeasts (E. coli, B. subtilis, P. pastoris, etc) for fermentation; mammalian cells (CHO, HEK, NS0, etc) and insect cells (Sf9) for cell culture.
BiBo Pharma has its own host cell system EPIC2BOX®, and our proprietary EPIC-CHO® system, including the commercially available CHO K1 and CHO GS systems, as well as the corresponding high-expression vector system and transfection process, ensures the high expression of the target proteins of our clients. Please refer to the introduction page for details.
Yes. We have both QA and QC departments in our GMP facility.
Our documentation quality is top-rated. Our team was trained to prepare the documentation like batch record and SOP using GMP standard through years of GMP tech transfer experience from previous world-leading CMO.
Since the production site became operational at the end of 2021, our Lingang site has been subjected to more than 20 quality audits from client‘s around the world, and on October 22, 2022, our Shanghai site GMP facility passed an online quality audit by the EU QP.
