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Serán BioScience
Accepting projectsPioneering Drug Development Solutions
About
Serán BioScience, LLC is a contract development and manufacturing organisation founded in 2016 and headquartered in Bend, Oregon, USA. It provides integrated drug product development, formulation and manufacturing — preformulation and API characterization, formulation and dosage form development, spray drying and particle engineering, analytical and quality control, and cGMP clinical manufacturing — with a focus on oral solid dosage forms and bioavailability enhancement. The company states it has grown to over 200 team members across two campuses in Bend comprising 12 facilities.
Strategic positioning
Spray-drying and particle-engineering development & manufacturing partner.
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.
9Specialized
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.
10Pilot / 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
Spray dryingParticle engineeringOral solid dosage
Scientific specialization
Spray-dried dispersionsParticle engineering
Modalities
Small moleculesBiologics
Live record · illustrative seed data · scores deterministic, rules-based — not AI. Not a regulatory determination or endorsement.