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Ascendia Pharmaceutical Solutions
Accepting projectsYour Partner from Pre-formulation to Commercialization
About
Ascendia Pharmaceutical Solutions is a US specialty CDMO offering pre-formulation, formulation development, analytical services, ICH stability studies and cGMP manufacturing for oral, topical and injectable products, with a stated focus on poorly water-soluble molecules and bioavailability enhancement. Its 60,000 sq ft North Brunswick, NJ facility is described as having Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms plus Class 100,000 (ISO 8) manufacturing suites, and both sterile and non-sterile manufacturing capability. The company states it is qualified to produce Phase I/II/III clinical trial materials and supports 505(b)(2) and ANDA development.
Strategic positioning
Nanotechnology-enabled formulation development for poorly soluble molecules.
Deterministic scores · rules-based, not AI iHow 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.
Modality focus iAdds 25 points if the profile flags advanced-therapy focus, 7 points per advanced modality listed (biologics, mAbs, ADCs, mRNA, LNP, cell and gene therapy, viral vectors, vaccines, proteins, oligos, peptides, radiopharma, biosimilars) capped at 45, 20 points for sterile capability, and 2 points per therapeutic area capped at 10. Levels: 75+ Advanced-therapy specialist | 50-74 Advanced-therapy active | 25-49 Selective | below 25 General process dev. Whether this dimension matters for you depends on your specific project.
7General process dev
Process-dev depth iCounts 3 points per service listed capped at 35, 6 points per distinct capability category capped at 30, 2 points per capability capped at 20, and 3 points per capability marked advanced or specialized capped at 15. Levels: 80+ Full-service process dev | 60-79 Broad capabilities | 40-59 Focused | below 40 Specialized. Whether this dimension matters for you depends on your specific project.
12Specialized
GMP readiness iBlends 5 points per regulatory agency experienced with capped at 30, GMP status (cGMP commercial 25, Clinical GMP 15, Pilot GMP 8, non-GMP 0), QMS maturity (Validated 15, Established 9, Basic 3), data integrity (ALCOA+ validated 15, Established 9, Basic 3), Annex 1 readiness (Compliant 10, In progress 5), and 5 for a contamination control strategy. Levels: 80+ Commercial GMP-ready | 60-79 Clinical GMP | 40-59 Developing GMP | below 40 Development-grade. Whether this dimension matters for you depends on your specific project.
0Development-grade
Scale-up iCombines commercial readiness (Commercial-ready 30, Late-stage 22, Clinical 14, Pilot 6), scale-up track record (Lab-to-Commercial proven 25, Clinical-to-Commercial 18, Pilot-to-Clinical 10, Lab-scale 3), 5 for pilot-scale and 10 for clinical-scale operations, 2 points per manufacturing technology capped at 15, and 5 for single-use systems. Levels: 80+ Commercial scale-up proven | 60-79 Late-stage scale-up | 40-59 Clinical scale | below 40 Pilot / early. Whether this dimension matters for you depends on your specific project.
15Pilot / early
Tech transfer iAdds 6 points per DOE/QbD methodology capped at 30, 5 points per PAT tool capped at 20, 5 points per automation system capped at 20, validation expertise (Full CQV 20, Established 12, Basic 4), and 10 if tech transfer appears in the listed services. Levels: 80+ Tech-transfer ready | 60-79 Strong tech transfer | 40-59 Established | below 40 Developing. Whether this dimension matters for you depends on your specific project.
0Developing
Analytical iCounts 8 points per capability in an analytical category capped at 40, 15 if analytical method development is a listed service, 15 if stability testing is a listed service, and 4 points per PAT tool capped at 15. Levels: 75+ Full analytical development | 55-74 Strong analytical | 35-54 Established | below 35 Basic. Whether this dimension matters for you depends on your specific project.
15Basic
Core expertise
NanoemulsionAmorphous solid dispersionNanoparticle formulation
Scientific specialization
NanoSol nanoparticlesAmorSol solid dispersionEmulSol nanoemulsionLipidSol lipid nanoparticles
Modalities
Small moleculesBiologics
ASC
Ascendia Pharmaceutical Solutions
Process development org · United States
Live record · illustrative seed data · scores deterministic, rules-based — not AI. Not a regulatory determination or endorsement.