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About
UGA Biopharma GmbH specialises in the development of monoclonal cell lines for the production of advanced biologics and biosimilars. Its development services cover cell line development, upstream processing, downstream processing with continuous critical-quality-attribute monitoring, and analytical method development. Its products include R2U-Cells — ready-to-use CHO-based cell lines for biosimilar candidates — and the proprietary CHO Prime® cell culture medium with matched Feed A and Feed B nutrient solutions. The company states that customers have used UGA Biopharma products in several clinical studies and obtained relevant market approvals.
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.
7Focused
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.
0Limited
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.
0Developing
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.
6Limited
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.
3Boutique
Capabilities
Process dev
Technology platforms
Proprietary CHO host cell line development platform; R2U-Cells ready-to-use cell lines for biosimilars; CHO Prime® media and feeds; First CHOice® single cell cloning and fed-batch medium platform
Therapeutic areas
BiosimilarsOncologyImmunology
Live record · illustrative seed data · scores deterministic, rules-based — not AI.