The Site That Does the Most
Of all Ardena’s European sites, Ghent carries the broadest scope. It is where solid state research happens. It is where oral solid development and manufacturing runs. It is also where sterile injectables, lyophilised products, and complex parenteral formulations are developed and manufactured under GMP. For a programme that spans multiple dosage forms or that needs solid state characterisation feeding directly into drug product development, Ghent is where those conversations happen in one building.
Solid State Research
The solid state research group in Ghent is dedicated to pre-formulation work: polymorph screening, salt and co-crystal screening, hydrate and solvate assessment, and the characterisation of physical and chemical properties that determine how a molecule will behave in a formulation. The team works with XRPD, DSC, TGA, DVS, and Raman spectroscopy as its core analytical toolkit.
What makes the Ghent setup particularly effective is the direct connection between solid state research and drug product development. The scientist who identifies the optimal salt form is part of the same organisation as the scientist who will formulate the tablet. Decisions made in pre-formulation are informed by what the downstream process can accommodate, rather than handed over in a report and interpreted by someone else months later.
Oral Solid Development and Manufacturing
Ghent’s oral solid development team covers the full formulation development pathway for tablets and capsules: pre-formulation, formulation screening, process development, and scale-up to GMP clinical batch manufacture. The site operates batch and continuous manufacturing capability for tabletting, granulation (wet and dry), film coating, and capsule filling.
PAT tools including near-infrared spectroscopy are integrated into the manufacturing environment, supporting blend uniformity monitoring and granulation endpoint determination. The team has experience with immediate release, modified release, and enteric-coated dosage forms, and with challenging APIs including poorly soluble compounds that require bioavailability enhancement strategies.
Sterile Manufacturing and Lyophilisation
The sterile manufacturing suite at Ghent provides aseptic fill-finish for vials and ampoules under Grade A conditions within a RABS environment. Lyophilisation capacity supports both conventional small molecule injectables and biologics requiring freeze-drying for stability.
The sterile manufacturing team has experience with complex injectable formulations including liposomal products and nanoparticle drug products requiring the specific process controls and in-process monitoring discussed in the broader nanomedicine fill-finish programme. Environmental monitoring and media fill qualification are maintained to EU GMP Annex 1 standards.
Analytical and Regulatory Support
Ghent’s analytical teams provide method development and validation for both oral solid and injectable products. The regulatory team in Ghent contributes to CMC dossier preparation for IND and IMPD submissions, with particular expertise in the solid state and oral solid sections of Module 3.
What Ghent Is Particularly Well Suited For
| Programme Type | Why Ghent Is a Good Fit |
| Early-phase oral solid with solid state uncertainty | Solid state research and formulation development in the same site; findings translate directly into formulation decisions |
| Poorly soluble oral API | HME, wet milling, and lipid formulation capabilities alongside solid state analytics |
| Sterile injectable for Phase I | Aseptic fill-finish under EU GMP; lyophilisation available; experienced with small clinical batches |
| Liposomal or nanoparticle injectable | Specialist experience in nanoparticle fill-finish process development; particle size monitoring during filling |
| Programme needing dual IMPD/IND filing | EU GMP certified site; regulatory team experienced in both jurisdictions |
| Continuous manufacturing evaluation | Batch and continuous manufacturing capability; PAT tools in place; team experienced in Q13 requirements |
Working with the Ghent Team
Projects based primarily at Ghent are managed by dedicated project managers who coordinate work across the solid state, formulation, analytical, and manufacturing teams within the site. For multi-site programmes, the Ghent project manager integrates with counterparts at Oss, Assen, Pamplona, and Somerset to ensure that the work is coordinated and that data flows between teams without friction.
