Every crystalline API can exist in more than one form, and each form behaves differently in the body and on the production line. We find the forms your molecule can adopt, tell you which of them matter, and explain under what conditions each one appears.
Knowledge of solid-state properties at an early stage of drug development helps avoid manufacturing problems, fine-tune the performance of drugs and provides space for innovation. By definition, every new crystal form is novel — it is not possible to predict how many forms can be prepared, how to prepare them, or the properties of forms still unknown.
The risk is asymmetric. A polymorph found during screening is a scientific result; the same polymorph appearing during scale-up, or after a batch has been on stability for a year, is a development crisis. Different polymorphs of the same molecule can differ in solubility, dissolution rate, melting point, hygroscopicity, mechanical behaviour and chemical stability — differences large enough to change bioavailability or to make a validated process stop working.
Screening also protects commercial position. A crystal form that has been discovered, characterized and shown to be reproducible can be claimed. Forms you never looked for can be claimed by someone else.
We design each screening around the questions that matter for your programme, not around a fixed catalogue of experiments.
A broad experimental search across solvents, temperature profiles, cooling and evaporation regimes, anti-solvent addition, slurry maturation and mechanochemical routes, to map the crystal forms the molecule can access.
For each form found, the conditions that produce it reproducibly — and the conditions that destroy it. This is what makes a form manufacturable rather than merely observed.
Ranking by thermodynamic stability, kinetic accessibility and development risk, so you know which forms deserve full characterization and which are laboratory curiosities.
Thermal behaviour, hydrate and solvate formation, moisture uptake, physical stability under temperature and humidity stress, and the relationships between forms.
Interpretation of how the form differences translate into dissolution, bioavailability and formulation behaviour — the reason the study was commissioned in the first place.
Clear documentation of each novel form, with the experimental evidence needed to support a solid-form patent application.
The programme is agreed with you before any experiment starts, and adapted as the chemistry reveals itself.
We characterize the material you send — crystallinity, purity, thermal profile, solvent content — so that every later result is referenced to a known starting point.
Solubility is measured across the solvent set. This is what makes the screening efficient: it tells us which solvents can realistically produce crystals and at what concentrations, instead of wasting API on conditions that cannot work.
Crystallization experiments run in parallel across the selected conditions, using the techniques appropriate to the molecule — cooling, evaporation, anti-solvent, slurry maturation, thermal cycling, mechanochemistry.
Every solid recovered is analysed, primarily by X-ray powder diffraction, and grouped into distinct crystalline forms. Unique patterns are flagged for full characterization.
Each relevant form is characterized thermally, spectroscopically and gravimetrically, and its relationship to the other forms established.
Forms of interest are stressed under temperature and humidity, and the preparation is repeated to confirm that the form can be made again — on purpose.
Results, raw data and interpretation are assembled into the final technical-scientific report, discussed with your team.
Our solid-state laboratory combines diffraction, thermal analysis, spectroscopy and microscopy, so that a form is never assigned on the strength of a single measurement.
The deliverable is a detailed technical-scientific report — the document your development, regulatory and IP teams will actually work from.
Polymorphs are different crystal packings of the same molecule. Hydrates and solvates contain water or solvent molecules built into the crystal lattice, so they are different in composition as well as in packing. A screening covers all three, because all three can appear unexpectedly during development.
There is no way to predict this in advance, and any laboratory that promises a number is guessing. Some molecules are monomorphic under every condition tested; others produce a dozen forms. What we can commit to is the breadth of the search and the rigour of the characterization.
Timelines depend on the scope agreed with you — the number of crystallization conditions explored, the techniques required and the amount of characterization work on the forms found. We define the duration together with the study plan, before the project starts, and keep you updated as results come in rather than only at the end.
The quantity depends on the type of study and on how many conditions and techniques are involved. We tell you the exact amount when we scope the project, and we design the experimental plan to work with the material you have available — early-phase programmes often have very little API to spare.
Yes. Our facility is authorized to handle high-potency active pharmaceutical ingredients up to OEB5, and controlled substances under Ministry of Health authorization, under GMP certification issued by AIFA and following FDA inspection.
Every project ends with a detailed technical-scientific report: experimental conditions, raw analytical data, interpretation and conclusions, written so that it can be used directly in your development documentation and regulatory filings.
Work starts only after a confidentiality agreement is in place. Samples, data and reports remain yours, and results are never shared or reused. We routinely handle undisclosed structures and early-phase candidates.
Send us the molecule and what you need to know about it. We will come back with a screening plan, the material requirement and a timeline before any work begins.