Scale is where a process proves itself. We take synthesis and crystallization from grams to kilograms, and hand back a procedure that behaves the same way at the next scale up.
We can optimise synthesis and crystallization processes, ranging from synthetic route scouting to process scale-up, allowing for batches of grams to kilograms of small-scale non-GMP production — while ensuring flexible and robust procedures that can easily be transferred to pilot scale and finally to high-volume industrial production of APIs that exhibit consistent and optimised physical and bulk properties.
That last clause is the difficult part. A scale-up that delivers the right molecule at the right purity but the wrong particle size, the wrong crystal form or an unfilterable slurry has not succeeded. Mixing, heat transfer and supersaturation profiles all change with vessel geometry, and each of them can move the solid-state outcome.
Running development batches at kilogram scale is how those effects are found while they are still cheap to fix. Our multi-purpose kilolab units at 50 L are sized for exactly that: large enough to be representative, small enough to iterate.
The work is scoped to where your process stands, from a laboratory procedure that has never left the flask to a transfer package for a receiving plant.
Batches from grams upward to support formulation, stability, toxicology and analytical method development, with the material characterized as it is made.
Non-GMP supply at kilogram scale in multi-purpose kilolab units of 50 L, for preclinical and development programmes.
Deliberate investigation of how mixing, cooling rate, heat transfer and addition profile shift with scale, and which of them the process is sensitive to.
Confirmation at every scale that crystal form, particle size distribution and bulk properties hold, rather than assuming they do.
Mapping of the operating window, so the receiving site knows which parameters are critical and how much latitude each one has.
Documented parameters, in-process controls and acceptance criteria, in a form a pilot plant or industrial site can execute.
Each scale is treated as an experiment with a question attached, not as a larger repeat of the last one.
We reproduce the procedure as written at laboratory scale. This alone usually identifies where the real difficulty lies, before any change is proposed.
Crystal form, purity, particle size distribution, bulk density and residual solvents are agreed as the criteria the scaled process has to meet.
The parameters most likely to be scale-sensitive are identified and studied — agitation, cooling profile, addition rate, seeding, hold times.
The process is executed at increasing scale with full analytical follow-up, comparing every batch against the target profile.
Batches are run in the kilo-lab at up to 50 L, under the conditions intended for transfer.
Filtration, washing and drying are optimised on real process slurries, since these frequently become the bottleneck at scale.
Batch records, analytical data and the process description are assembled into the technical-scientific report and transfer package.
The kilo-lab is equipped for controlled, monitored operation rather than for volume alone, so that each batch produces understanding as well as material.
Deliverables are the material itself and the documentation that lets the process be run again elsewhere.
Our manufacturing activity is non-GMP: development batches and kilogram-scale supply for preclinical and development use. The analytical laboratory is separately GMP certified by AIFA and FDA inspected, so testing can be carried out under GMP where your programme requires it.
Yes, and it is common. We start by running it as written, which is usually the fastest way to locate the actual problem, and only then propose changes.
It is one of the main reasons to scale up in a controlled environment. We monitor the form at every scale, and when it moves we investigate why — usually supersaturation profile, seeding or agitation — and adjust the process rather than accept the new form by default.
From grams for early development up to kilogram scale in our kilo-lab. We confirm what is achievable for your specific chemistry when we scope the project.
Timelines depend on the scope — the complexity of the chemistry, the scale required and how much process development is still needed. We agree the schedule with you before work begins and keep you updated as batches run.
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 synthesized 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.
Send us the current procedure and the quantity you need. We will tell you what the scale-up requires and what it will produce.