A crystallization that works once in a flask is not a process. We develop and optimize synthesis and crystallization procedures that hold their properties from grams to kilograms and transfer cleanly to industrial scale.
We optimise synthesis and crystallization processes — from synthetic route scouting to process scale-up — allowing batches from grams to kilograms during development, while ensuring flexible and robust procedures that can easily be transferred to pilot scale and finally to high-volume industrial production of API with consistent, optimised physical and bulk properties.
Scale changes the chemistry in ways that are easy to underestimate. Mixing, heat transfer, cooling rates, supersaturation profiles and residence times all shift with vessel size, and each of them can alter the crystal form, the particle size distribution, the filtration rate and the residual solvent content. A process developed without that in mind tends to work at laboratory scale and fail at the kilo-lab.
Our process optimization ensures flexible and robust procedures that transfer cleanly with optimised and consistent bulk properties — which is what a technology transfer package has to guarantee to be worth anything.
The work spans the synthesis and the crystallization, because the two determine the impurity profile and the solid-state outcome together.
Definition of the crystallization route — cooling, anti-solvent, reactive, evaporative or seeded — and the operating window that produces the target form reliably.
Real-time observation of supersaturation, nucleation and growth during the process, so that the mechanism is understood rather than inferred from the final powder.
Seed form, loading and addition point, which are frequently the difference between a process that controls polymorphism and one that gambles on it.
Deliberate variation of the critical parameters to establish how much latitude the process has before the product changes.
Filtration, washing and drying behaviour, optimised alongside the crystallization rather than treated as an afterthought.
Documented parameters, controls and acceptance criteria, in the form a receiving site can actually execute.
The programme progresses from understanding to control, and then to demonstration at the scale that matters.
Crystal form, purity, particle size distribution, bulk properties and residual solvents are agreed as targets before the process is designed.
Solubility curves and the metastable zone width are measured in the candidate solvent systems, which is what makes a crystallization designable rather than empirical.
The route, cooling or addition profile, seeding strategy and agitation regime are developed at laboratory scale with in-situ monitoring.
The ability of the crystallization to reject process-related impurities is quantified, and adjusted where the purity target requires it.
Critical parameters are varied deliberately to map the operating window and identify which ones actually need to be controlled.
The process is executed at increasing scale, up to kilogram batches in the kilo-lab, confirming that form, particle properties and purity hold.
Filtration, washing and drying are optimised on real process slurries, and residual solvent levels confirmed.
Parameters, controls, acceptance criteria and the supporting data are assembled into the technical-scientific report and transfer package.
Process development is carried out with the analytical support that makes each batch interpretable, not only reproducible.
The deliverable is a detailed technical-scientific report and, where the project includes production, the synthesized material itself.
Development batches from grams up to kilogram scale, with a kilo-lab equipped to 50 L. The point of running at that scale during development is to expose the problems that only appear when mixing and heat transfer stop being ideal.
Yes, and it is common. We would start by reproducing the existing process as written, which usually identifies quickly where the difficulty actually lies, before proposing changes.
Yes. Route scouting, synthesis optimization and crystallization are developed together, because the impurity profile the synthesis produces determines what the crystallization has to reject.
Timelines depend on the scope agreed with you — the complexity of the chemistry, the scale required and the depth of characterization. We define the duration together with the project plan, before work begins, and keep you updated as results come in.
It depends on the stage and the objective. For development work we start from whatever is available and scale up as the process is established. We confirm the requirement 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: experimental conditions, raw analytical data, interpretation and conclusions. Where the project includes production, the synthesized material is delivered alongside the report.
Work starts only after a confidentiality agreement is in place. Routes, data and reports remain yours, and results are never shared or reused. We routinely handle undisclosed structures and proprietary processes.
Tell us where the process stands and what it has to deliver. We will propose a development plan through to a transfer package.