Why a US Site Matters
For biotech companies based in North America, time zone alignment and proximity are not trivial. A development partner eight hours ahead means decisions made in the afternoon do not get actioned until the next day. Equipment access, sample shipping, and site visits all become harder when the facility is on another continent.
Ardena’s Somerset, New Jersey site gives North American sponsors a US-based manufacturing partner with direct access to the oral solid and bioavailability enhancement capabilities the Ardena network is known for. The same scientific standards, the same quality systems, the same integrated project management, but in the same time zone.
What the Site Does
Spray Drying for Amorphous Solid Dispersions
Somerset’s core strength is spray-dried amorphous solid dispersion (ASD) manufacture. The site operates laboratory and GMP-scale spray drying equipment with closed-loop solvent recovery and secondary drying capability. The formulation team has developed ASDs across a wide range of BCS Class II molecules and polymer systems, including HPMC-AS, PVPVA, and PVP-K grades.
Development programmes at Somerset start with feasibility: does this molecule respond to ASD? If yes, which polymer gives the best balance of dissolution performance, physical stability, and processability? From there, the team scales through development batches to GMP clinical manufacture within the same facility, with no formal tech transfer between scales.
Hot Melt Extrusion
HME capability at Somerset serves molecules where spray drying is less suitable, typically thermally stable APIs where a solvent-free process is preferred or where the downstream processing of a spray-dried powder presents challenges. The site’s HME expertise covers twin-screw extrusion, extrudate milling, and downstream tabletting or capsule filling of the milled intermediate.
Downstream Oral Solid Manufacturing
Somerset handles the full downstream processing chain for ASD-based products: granulation where required, blending, tabletting, and capsule filling. Analytical capabilities support content uniformity, dissolution testing, and stability studies from development through to GMP release.
Who Somerset Is Built For
| Programme Type | Why Somerset Is a Good Fit |
| BCS Class II molecules needing ASD strategy | Spray drying and HME under one roof; formulation screening to GMP clinical batch at a single site |
| North American sponsors wanting US-based manufacturing | Same time zone; direct site access; FDA cGMP operations; no import/export logistics for US clinical supply |
| Programmes requiring dual US/EU clinical supply | Somerset provides FDA cGMP US supply; Ghent or Pamplona provides EU GMP supply under coordinated Ardena project management |
| Early-phase ASD feasibility with tight timelines | Rapid screening capability; formulation team responds quickly; no transatlantic coordination overhead |
| IND-stage oral solid programmes | Experience preparing CMC sections for IND submissions; regulatory team aligned with FDA expectations |
The Connection to the European Network
Somerset is not an isolated US operation. It is a node in the Ardena network, with direct scientific and project management connections to Ghent, Oss, Assen, and Pamplona. For programmes where solid state work needs to happen in Ghent before formulation development begins in Somerset, the handoff is internal. For programmes requiring EU GMP supply for European trials alongside US supply from Somerset, a single project manager coordinates both.
That integration removes the coordination overhead that sponsors would otherwise manage themselves when using a US development house alongside a separate European manufacturer.
