Kemwell Biopharma is a biologics-focused contract development and manufacturing organization in Bengaluru, India, established in 1980, whose facility was built with technological support from a leading German biopharma company. It provides integrated drug substance and drug product services from the same site, covering process, formulation and analytical development and cGMP clinical and commercial manufacturing of mammalian cell-culture products including monoclonal antibodies, bispecific and multispecific antibodies, fusion proteins and recombinant proteins. Drug product capability covers liquid and lyophilized vials and isolator-based prefilled syringe filling.
Manufacturing iCounts how many of the 22 core manufacturing capabilities this profile lists (7 drug-substance, 6 drug-product, 5 advanced-therapy, 4 specialized) - each adds 3.6 points, capped at 78 - plus 2.4 points per therapeutic area covered, capped at 22. Levels: 80+ Full-spectrum CDMO | 60-79 Broad capability | 40-59 Established | below 40 Focused. Whether this dimension matters for you depends on your specific project.
19Focused
Advanced therapy iCounts the 5 advanced-therapy capabilities (cell therapy, gene therapy, viral vectors, CAR-T, exosomes) at 11 points each, capped at 50, then adds bonuses for related depth: biologics drug substance 14, mRNA 12, viral vectors 10, CAR-T 8, plasmid DNA 6. Levels: 80+ ATMP leader | 60-79 Advanced | 40-59 Emerging | below 40 Limited. Whether this dimension matters for you depends on your specific project.
25Limited
Fill-finish iCounts the 6 fill-finish capabilities (vial, syringe, cartridge, blow-fill-seal, isolator, RABS) at 8 points each, capped at 42, plus 16 for sterile injectables, 12 for isolator filling, 8 for RABS. Suite count adds up to 22 more (22 at 20+ suites, 16 at 10+, 10 at 5+, 5 for any). Levels: 80+ High-capacity sterile | 60-79 Strong | 40-59 Capable | below 40 Developing. Whether this dimension matters for you depends on your specific project.
52Capable
Quality iBlends GMP certification (16), Annex 1 compliance (14) and a data-integrity program (10) with reported metrics: inspection pass rate up to 24, quality score up to 18, plus bonuses for low CAPA counts (up to 8) and few audit findings last year (up to 10 for zero). Shows Not reported (score 0) when no GMP flag, pass rate, quality score or data-integrity program is on file. Levels: 80+ Exceptional | 60-79 Strong | 40-59 Solid | below 40 Developing. Whether this dimension matters for you depends on your specific project.
0Not reported
Regulatory iCounts entries in three profile lists: regulatory history (6 points each, capped at 46), inspection authorities (7 points each, capped at 30) and geographic coverage (6 points each, capped at 24). More filings, more agencies and wider geography all raise the score. Levels: 80+ Global reach | 60-79 Multi-region | 40-59 Regional | below 40 Limited. Whether this dimension matters for you depends on your specific project.
18Limited
Capacity iTiers four scale metrics: facilities (up to 28 points at 30+), manufacturing suites (up to 24 at 40+), annual unit capacity (up to 26 at 1,000,000+) and employee count (up to 22 at 10,000+). Each metric earns partial points at lower tiers, so any reported scale contributes. Levels: 80+ Global scale | 60-79 Large | 40-59 Mid-size | below 40 Boutique. Whether this dimension matters for you depends on your specific project.
0Boutique