Loading…
Enzene Biosciences
Biologics innovation begins with Enzene
About
Enzene is a global biologics CDMO and biosimilar developer offering integrated services across drug discovery, development and commercial supply, built around its patented EnzeneX fully-connected continuous manufacturing (FCCM) platform. Its Chakan (Pune, India) manufacturing site has six drug substance suites covering both fed-batch and continuous manufacturing at 20 L to 2000 L, plus fully automated drug product fill-finish of vials, prefilled syringes and cartridges; a separate 75,000 sq ft Pune R&D facility runs cell line development through fill-and-finish. Enzene Inc. operates a GMP drug substance facility at the Princeton West Innovation Campus in Pennington, New Jersey. Modalities stated include monoclonal antibodies, bispecific proteins, conjugated proteins and biosimilars.
Deterministic scores · rules-based, not AIiHow these scores are obtained: each one is computed from this profile's listed attributes — capability checkboxes, certifications, capacity figures and coverage — by a fixed formula, recomputed on every page load. Deterministic and rules-based means the score comes from a fixed, transparent formula over listed attributes — the same inputs always produce the same score. It is not AI: there is no model, no learning, and no hidden weighting. Whether a score is relevant to you depends on your specific project: a capability that raises the number may not matter for your work, and a niche strength your project needs may barely move it. Capability scores are a directional starting point, not a verdict. A lower score does not disqualify a company or consultant, and no decision should rest on the score alone — always contact the company directly to confirm the specifics for your project.
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.
14Focused
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.
14Limited
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.
40Capable
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
Capabilities
Sterile fill-finishBiologicsVial fillingSyringe fillingProcess devCommercial mfg
Technology platforms
EnzeneX fully-connected continuous manufacturing (FCCM); mammalian and microbial drug substance manufacturing; automated vialprefilled syringe and cartridge fill-finish
Therapeutic areas
BiosimilarsOncologyImmunology
Live record · illustrative seed data · scores deterministic, rules-based — not AI.