With mature plasmid process development and GMP production capacity, we are available to help customers shorten the development cycle and quickly match IND/BLA.
Specific host strains can be selected according to the characteristics of different plasmid products, and the preparation and verification of seed banks can be completed following regulation requirements.
We have development experiences in plenty of projects, master cutting-edge technologies, which ensures the continuous and stable supply of production materials, and helps customers establish high-level plasmid preparation technology.
We can provide technology transfer and GMP production for smooth and efficient large-scale manufacturing.
Our teams have mature experience in providing lentivirus process development and GMP production services to help customers shorten the development cycle and quickly match IND/BLA requirements.
We also support the preparation and verification of cell bank.
We offer suspension-based processes or adherent processes at various scales with downstream purification to meet versatile requirements.
We can provide technology transfer and GMP production for smooth and efficient large-scale manufacturing.
Based on Quality-by-Design (QbD) concept , our process development platform includes not only cell-selection, cell-stimulation, cell-transduction, cell-expansion, cell-formulation services, but also process development services.
We can support the development and commercial production of CAR-T autologous product, NK cell therapeutic product and antibody combinational cell therapeutic product.
Support cell banking and characterization on bank-typed cell therapy products.
We provide full-stack assay method development and validation service for plasmids, viruses, cell therapy and gene therapy products, including batch release, stability studies, and product characterization, meeting customer filing needs and regulatory requirements.
We develop Critical Quality Attributes (CQA) for products based on Quality-by-Design (QbD) and provide comprehensive product quality research services for cell therapy and gene therapy.
Well-established platform of analytical method development and validation were built for plasmids, viruses, cell therapy and gene therapy products.
