In the past two decades, we are specialized in molecular and cellular engineering of CHO cells to select stable and high productivity serum-free suspension clones to express therapeutic proteins.
For commercialization, we have experience in developing and manufacturing GMP grade proteins for preclinical and clinical development, including at least 4 innovative monoclonal antibodies(mAbs) and more than 10 biosimilar or biobetter protein drugs.
We are well-equipped for cell line development with BD Flow Cytometry, Nikon Inverted microscope, Cellometer T4 Plus, automated clones picking system-MD ClonePix™ 2 , high-resolution imaging system and MD cell-select imager in place. Our technical expertise combined with well-equipped facilities enable us to establish timely and reliable high-performance production cell lines for industrial scale production.
We have more than 10 years of experience in designing and developing simple, robust, and scalable CHO cell culture processes at 2L scale. Projects we have conducted include anti-CD4 mAb (phase II trial), EPO biosimilar (phase III trial), anti-HSV mAb (phase I trial), Trastuzumab biosimilar (phase I) and our in-house therapeutic protein pipelines.
We have established Quality-by-Design (QbD)-based medium screening and optimization platform using Design of experiment (DoE) methodology. We are experienced in optimization of cell culture condition and feeding strategy to achieve high culture titer (current productivity level of 5 to 6 g/L) to support batch, fed-batch, multiple harvest and perfusion process platforms. We are also experienced in seed culture development with high cell density in shaker flasks and wave perfusion bioreactors, simplifying the scale-up process with high seeding ratio (up to 36-fold).
We are well-equipped with DoE comparable incubator shaker and 2L bioreactors, wave bioreactor, 30L stainless steel (SS) bioreactor, 150L SS bioreactor, cell culture metabolite analyzer, Auto-cell counter and Single-use clarification skid, all critical for cell culture process development.
Our team has extensive experience in the design of robust protein purification processes to achieve optimized yields (recovery rate 70 to 75%) through combined use of different chromatography and filtration technologies. We are experienced in the design and execution of viral clearance and viral removal validation studies. We have expertise in establishing purification in scale-up or scale-down model.
We are well-equipped for protein drug purification process development with ÄKTA Avant 25, ÄKTA Pure 150, ÄKTA crossflow, ÄKTA Explorer, ÄKTA Prime, ÄKTA Pilot, ÄKTA Process, UniFlux™ System and high throughput media screening system in place, set to allow high-precision execution.