Advance one formulation or process route, scale, facility, campaign or transfer option only after product quality, process robustness, equipment fit, finite resources, economics, environmental inventory and validation evidence remain consistent.
Independent company use-case study · pharmaceutical CDMO
CatalentFive process decisions
Choose one use case. Add authorised plant data. Test capacity, cost and constraints.
Decision brief
One question. One model.
One authorised small-molecule, biologic or other pharmaceutical programme and one declared development-to-manufacturing process, including materials, formulation, unit operations, packaging or supply handoffs, cleaning, utilities, quality holds and waste.
Five practical use cases
Five places to start.
Evaluation scopes for Catalent—not claims of current software use.Compare development and manufacturing routes
Connect formulation or cell-line choice, unit operations, analytics, dosage-form or drug-substance handoff and packaging on one material, quality, equipment, time and uncertainty basis.
Screen scale-up, transfer and facility fit
Translate authorised development evidence into mixing, heat and mass transfer, formulation, filtration, chromatography or packaging-load envelopes, then test approved target equipment and utilities.
Test multiproduct CDMO campaigns offline
Schedule eligible manufacturing, packaging, cleaning, laboratory, cold-chain and release resources without representing Catalent customers, actual site capacity, occupancy or delivery commitments.
Compare process and facility TEA/LCA scenarios
Evaluate formulation, process, single-use, facility, packaging or supply options across accepted output, materials, energy, water, waste, capital and operating cost under one boundary.
Govern technology-transfer and validation evidence
Link process history, formulations, scale assumptions, analytical methods, risks, engineering and GMP runs, deviations and acceptance criteria without performing formal validation or batch release.
Action pack
Inputs in. Decisions out.
- Molecule, modality, dosage form, quality and demand basis
- Formulation, process, recovery, stability and analytical evidence
- Equipment eligibility, scale rules, hold times and facility limits
- Materials, consumables, utilities, waste, cost and lifecycle factors
- Development and process-route comparison
- Scale-up, transfer and facility-fit evidence map
- Finite CDMO schedule and accepted-capacity range
- TEA/LCA screen and validation-readiness register
- Select one customer-authorised development or transfer decision.
- Declare product, quality, facility and transfer boundaries.
- Import development, analytical and equipment evidence.
Evidence and limits
Public evidence only.
- Catalent — AboutOfficial current context for Catalent's end-to-end development and manufacturing scope and proprietary technology history.
- Catalent — Novo Holdings acquisitionOfficial legal and ownership context confirming Catalent became a privately held company under Novo Holdings.
- Catalent — Former Bloomington site boundaryOfficial current clarification that Bloomington and two other sterile fill-finish sites transferred to Novo Nordisk in December 2024.
- Catalent — Current locationsOfficial current network by modality, location and facility type used to keep facility scope separate from former sites.
- Catalent — Tampa headquartersOfficial current boundary confirming Catalent's global headquarters moved to Tampa in September 2025.
- Catalent — Somerset sale agreementOfficial evidence of an announced sale agreement, without treating the transaction as completed absent a later first-party confirmation.
- Catalent — Biologics discoveryOfficial context for Catalent's own GPEx Lightning, SMARTag and integrated biologics-development services.
- Catalent — OptiForm Solution SuiteOfficial context for Catalent's own oral-dose formulation screening, development and manufacturing programme.
- Catalent — FastChain clinical supplyOfficial context for Catalent's own demand-led clinical-supply, forecasting, packaging and distribution capabilities.
- Catalent — OneHub portalOfficial context for Catalent's own inventory, shipment, document and milestone visibility portal.
- Catalent — Qai quality toolOfficial current context for Catalent's own enterprise AI tool supporting quality processes, investigations and CAPA work.
Guardrail: No Catalent, Novo Holdings, Novo Nordisk or customer molecule, formulation, process, site, campaign, capacity, occupancy, yield, cost, environmental result, deployment or digital system is represented. The three former sterile fill-finish sites transferred to Novo Nordisk are outside Catalent's current network. Technology transfer, validation, PPQ, GxP, batch release, regulatory and commercial decisions remain under approved company and customer systems.