Process maps
From cell line to fill-finish, step by step
20 manufacturing processes laid out step by step. For each step: the reference method and why it is the standard, the equipment and makers behind it, the reagents, and the alternatives used in practice. Each equipment category links to the companies that sell it in Japan.
Gene therapy
- AAV vectorsThis reference process map organizes the manufacture and analysis of AAV vectors in the order of upstream → downstream (purification) → formulation…30 steps
- Lentiviral vectorsThis reference process map organizes the manufacturing and analysis of lentiviral vectors in the order production → harvest and clarification →…17 steps
- Plasmid DNAThis reference process map organizes the manufacturing and analysis of plasmid DNA in the order of E. coli fermentation → cell harvest and lysis →…27 steps
Antibodies
- Monoclonal antibodiesThis reference process map lays out monoclonal antibody manufacturing and analytics in process order, from cell line development to characterization.…23 steps
- Antibody-drug conjugates (ADC)This reference process map lays out antibody-drug conjugate (ADC) manufacturing and analytics in order: antibody supply → conjugation → purification…19 steps
- Bispecific antibodiesThis reference process map organizes the manufacture and analysis of bispecific antibodies (BsAb) in the order of expression, purification,…15 steps
- Antibody fragmentsThis reference process map organizes the manufacture and analysis of antibody fragments (Fab, scFv, VHH, etc.) in the order of expression,…18 steps
- Cell-free ADCThis reference process map lays out cell-free ADC manufacturing and analytics in order: cell-free synthesis → site-specific conjugation →…20 steps
- Continuous manufacturing (integrated)This reference process map organizes integrated continuous manufacturing of antibodies in the order of continuous culture, continuous purification…19 steps
Cell therapy
- CAR-T cell therapyThis reference process map organizes CAR-T cell therapy manufacturing and quality control in the order cell collection → activation → gene transfer →…18 steps
- iPS cellsThis reference process map organizes iPS cell reprogramming and establishment → expansion → differentiation → characterization in process order. The…19 steps
- Mesenchymal stem cells (MSC)This reference process map organizes the manufacturing and quality control of mesenchymal stem cells (MSC) in the order isolation → expansion culture…17 steps
Nucleic acid therapeutics
- mRNA-LNPThis reference process map organizes the manufacturing and analysis of mRNA-LNP in the order of synthesis by IVT → capping → purification → LNP…20 steps
- siRNAThis reference process map organizes the manufacture and analysis of siRNA in the order of solid-phase synthesis, deprotection, purification,…17 steps
- Antisense oligonucleotides (ASO)This reference process map organizes the manufacture and analysis of antisense oligonucleotides (ASOs) in the order of solid-phase synthesis →…16 steps
Microbial fermentation
- E. coliThis reference process map organizes E. coli production and analysis in the order fermentation → cell harvest and disruption → purification →…25 steps
- YeastThis reference process map organizes yeast production and analysis in the order fermentation → harvest → purification → characterization. The best…19 steps
- Filamentous fungiThis reference process map organizes production and analysis with filamentous fungi (Aspergillus, etc.) in the order fermentation → harvest →…19 steps
Small molecules
- Chemically synthesized APIsThis reference process map organizes the chemical synthesis and analysis of small-molecule APIs in process order: reaction → workup and…20 steps
- Flow synthesisThis reference process map organizes small-molecule flow synthesis and analysis in the order of continuous reaction, in-line analysis and workup. The…19 steps