The last step decides what the material actually is. Filtration, washing and drying set residual solvent, particle integrity, form and flow — and they are where scale-up most often stalls.
Complete downstream isolation capabilities to deliver dry, characterized solids ready for the next development stage — including spray drying for amorphous dispersions and engineered particles.
Isolation is routinely treated as a formality after the crystallization, and it routinely turns out to be the bottleneck. A slurry that filters in minutes at laboratory scale can take hours in a larger filter; a wash designed to remove mother liquor can dissolve the product or convert its form; drying can desolvate a hydrate, collapse an amorphous dispersion or cause attrition that destroys the particle size distribution the crystallization was designed to deliver.
We develop isolation alongside the crystallization rather than after it, and characterize the material at each stage — wet cake, dried solid — so that any change is attributed to the step that caused it.
The objective is a dry, characterized solid whose properties are the ones the process intended.
Filtration behaviour assessed on real process slurries, including cake resistance and the effect of crystal habit and particle size on filtration rate.
Wash solvent and volume optimised to displace mother liquor without dissolving the product or triggering a form change.
Drying profiles developed to remove solvent to specification without desolvation, degradation, attrition or agglomeration.
Spray drying for amorphous solid dispersions and engineered particles, with the process parameters that govern morphology and residual solvent.
Residual solvent levels measured against ICH Q3C limits, and the drying process adjusted until they are met.
Confirmation that crystal form, particle size, surface area and flow behaviour survived isolation unchanged.
Each step is assessed for what it does to the material, not only for whether it removes liquid.
The process slurry is characterized as it comes off the crystallization — solids content, particle size, habit, filtration behaviour.
Filtration is tested on representative slurry, with cake resistance measured and the effect of crystal properties on filterability established.
Wash solvent, volume and temperature are selected to displace impurities without dissolving product or converting the form, with the wet cake analysed after.
Drying profiles are developed and the material analysed through the cycle, watching for desolvation, form change, degradation and attrition.
For amorphous dispersions and engineered particles, spray drying parameters are developed against the target particle and stability profile.
Residual solvents are quantified and the drying endpoint set on data rather than on elapsed time.
The dried solid is characterized in full and compared against the target profile.
Process parameters, analytical results and the isolation rationale are documented in the technical-scientific report.
Isolation equipment is supported by the analytical laboratory throughout, so that each step is verified rather than assumed.
Deliverables are the dry characterized material and the documentation of how it was isolated.
Usually, but often upstream rather than downstream. Poor filtration is generally a crystal habit or particle size problem created by the crystallization, so we look at both ends. Treating it only as a filtration problem is what makes it persist.
Yes, and it is one of the most common ways a form is lost late in a process. Hydrates and solvates are particularly vulnerable. We analyse the material through the drying cycle rather than only at the end, so a change is caught where it occurs.
Yes. Spray drying is the route we use most for amorphous solid dispersions, because it scales predictably and the parameters that govern particle morphology and residual solvent can be controlled deliberately.
Timelines depend on the scope — the complexity of the chemistry, the scale required and how much development is still needed. We agree the schedule with you before work begins and keep you updated as batches run.
From grams for early development up to kilogram scale in our kilo-lab. We confirm what is achievable for your specific material when we scope the project.
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.
A detailed technical-scientific report covering the process, the parameters and the analytical results — and, where production is in scope, the material itself with its characterization data.
Work starts only after a confidentiality agreement is in place. Routes, parameters, data and reports remain yours and are never shared or reused.
Tell us where the isolation is failing — filtration, drying, residual solvent, form change. We will develop the step and characterize what comes out.