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Selecting the solid form is a key development milestone and helps shape everything that follows, from how well the material will formulate, to how easy the formulation will be to manufacture, and what its shelf life will be. It also introduces opportunities for new IP with the potential to add value to an asset and extend exclusivity.

We carry out systematic, risk-aware screening and characterisation of all viable solid forms, and help you identify and progress the right one for your programme.

Where a complex or metastable form is unavoidable, we help you understand it and manage it with confidence through every development stage.

Capabilities

Solubility screening

Salt, co-crystal, hydrate and solvate screening 

Polymorph screening and relative stability assessment

PXRD (including controlled temperature and humidity) 

DSC

TGA

Dynamic Vapour Sorption

Hot stage microscopy 

IR and NIR spectroscopy

Particle attributes — purity, size, shape and surface characteristics — are directly linked to formulation quality, and determine how a drug substance behaves during processing and manufacture.

We design and engineer crystallisation processes that deliver the particle properties your programme needs. And if an existing process is underperforming, we identify the root cause and fix it.

The goal is always to deliver particles and processes that behave consistently and predictably, from lab scale through to commercial manufacture, and formulations that don’t rely on compensatory workarounds.

Capabilities

Solubility and metastable zone width curve measurement

Process design, optimisation and scale-up (1mL–5L automated lab reactors)

Wet and dry milling

Spherical crystallisation and co-processing

Process analytical technologies (Mettler Toledo FBRM™, BlazeMetrics BlazeBasic™)

Filtration and drying studies 

Chemical and physical product characterisation

We go well beyond the standard characterisation toolkit, providing interpretation and context around not only particle size and shape, but surface properties and bulk powder properties as well. By understanding how particles interact with each other you can begin to correlate specific particle attributes with real manufacturing outcomes such as flow, compaction and sticking.

Whether you’re designing a robust process from the ground up or troubleshooting unexpected behaviour, the right characterisation data turns uncertainty into confidence.

Capabilities

Particle size measurement, method development, validation and AMTE (dry and wet dispersion)

Particle shape distribution and agglomeration assessment 

Polarised light microscopy

Atomic force microscopy 

Surface area and porosity 

Surface energy

Bulk, tapped and true density

Effective formulation starts with knowing the particle properties of the API. Using a Quality by Design framework, we develop fit-for-purpose formulations for solid oral dosage forms that are bioavailable, stable and appropriate for the stage of development.

Where a formulation is underperforming, we trace the problem to its root cause — which is often found in the underlying particle properties — and address it there.

The result is formulations built for predictable performance, from development through to manufacture.

Capabilities

Flow measurement

Formulation development including compressibility and sticking propensity 

Mechanical sieving

Granulation

Tablet press

Hardness, friability and tensile strength testing

Disintegration testing