A contract research and manufacturing organization, leader in solid-state chemistry and API crystallization — serving pharmaceutical clients worldwide for over 20 years.
PCL Research & Manufacturing s.r.l. provides reliable solutions to optimise and control the crystallisation process of Active Pharmaceutical Ingredients for pharmaceutical companies — since 2005.
Our mission is to support clients during drug development, helping them reduce batch failure, avoid costly crystallisation issues and overall offer greater confidence in drug quality. We are a high-performing, cohesive team of trained chemists and analysts with more than 20 years of experience in API crystallization.
What distinguishes us is the combination under one roof: a GMP-certified analytical department, authorisation for controlled substances, containment for highly potent compounds to OEB5, and full structure determination. Programmes that would normally be split across three suppliers stay with one team.
Years experience
HPAPI capability
AIFA certified
Inspected facility
An active ingredient can crystallise in several distinct solid forms. Each one is the same molecule, arranged differently — and each behaves differently in the body, on the production line and on the shelf.
Solubility, dissolution rate, bioavailability, hygroscopicity, chemical stability, filterability, flow, compressibility and shelf life all follow from the solid form, not from the molecular structure alone. Choose the wrong form, or fail to detect a more stable one, and the consequences surface late: a batch that will not filter, a tablet that fails dissolution, a product that converts on stability at month eighteen.
A more stable form that emerges after launch can force reformulation, re-filing and supply interruption. Thorough early screening is the only reliable defence.
Salts, co-crystals and amorphous dispersions can raise apparent solubility by orders of magnitude — when the right partner and the right process are found.
A crystallisation that works in a flask can fail in a reactor. Understanding nucleation, growth and the metastable zone is what makes it transfer.
Novel forms are patentable and defensible. Complete structural characterisation, including absolute configuration, underpins both filing and freedom to operate.
Every euro spent understanding the solid form early is spent instead of a reformulation later.
This is the principle our services are built on: find the forms that exist, understand why they exist, select the one that will survive development and manufacturing, and document it well enough to defend.
Full-spectrum analytical capabilities in top-class laboratories — GMP certified by AIFA, FDA inspected, and authorized for highly potent compounds up to OEB5.
Our analytical department works both as a standalone testing service and as the backbone of every R&D and CDMO programme we run. The same quality system covers release testing for commercial APIs, method development for compounds still in discovery, and the characterisation work that supports regulatory filings in the EU and the US.
Release and stability testing for APIs and intermediates, under our AIFA-certified quality system.
ICH-compliant development, validation and transfer of analytical methods.
Full API characterisation: identity, purity, impurities, residual solvents, water content.
Ministry-of-Health authorised handling, containment validated to OEB5.
| Technique | What it answers |
|---|---|
| XRPD | Which crystalline form is present; detection of form mixtures and conversion. |
| DSC & TGA | Melting, transitions, desolvation, thermal stability and solvate stoichiometry. |
| HPLC / UPLC | Assay, related substances, impurity profiling, dissolution quantification. |
| FT-IR & FT-Raman | Salt versus co-crystal discrimination, hydrogen bonding, form identity. |
| DVS | Hygroscopicity, hydrate formation and critical relative humidity. |
| Particle size analysis | Size distribution and its effect on dissolution, flow and content uniformity. |
| Optical & hot-stage microscopy | Crystal habit, agglomeration, transitions observed in real time. |
| Dissolution & solubility | Intrinsic and apparent solubility, pH dependence, biorelevant media. |
Knowing exactly how a molecule sits in the crystal lattice — and which enantiomer you are working with — underpins patent protection, regulatory submissions and process understanding.
Each technique answers a different question, and together they cover the full range of samples encountered in drug development: from well-formed single crystals to sub-micron powders that cannot be grown any larger. Where one method reaches its limit, another takes over.
Lab-instrument and synchrotron-based collection. Full three-dimensional structure solution and refinement, absolute configuration of chiral molecules, and unambiguous characterisation of salts, co-crystals, solvates and hydrates.
Neutrons locate hydrogen atoms precisely where X-rays cannot. This resolves hydrogen-bond networks and proton transfer, settling the salt versus co-crystal question that regulators increasingly ask.
MicroED solves structures from crystals a thousand times smaller than single-crystal XRD requires. No crystal growth campaign, minimal sample consumption, results from intractable powders.
From the discovery of your new solid form to the optimisation of your process — saving you time and risk.
Our screening campaigns are designed, not run by rote. We select solvents, conditions and crystallisation techniques based on the molecule in front of us, and we interpret what comes out: which forms are real, which are transient, which will hold up through manufacturing and storage.
Broad solvent and condition screens to map the form landscape and identify the thermodynamically stable form.
Counter-ion selection for ionisable compounds, balancing solubility, stability and processability.
A route to improved properties for neutral molecules that cannot form salts.
A reasoned recommendation with the data behind it, not just a list of hits.
Polymer selection and stability assessment where crystalline solubility is insufficient.
Metastable zone, seeding strategy and cooling profile — designed to transfer to the plant.
Material assessment, solubility mapping, technique selection.
Parallel crystallisations across solvents, temperatures and methods.
XRPD, thermal, spectroscopic and structural analysis of every hit.
Stability ranking, interconversion study, documented recommendation.
Contract development and non-GMP manufacturing that bridge the gap between R&D and supply.
We optimise synthesis and crystallisation processes from grams to kilograms, producing flexible, robust procedures that transfer cleanly to pilot scale with consistent bulk properties. Because the same team ran the screening, the process inherits the form knowledge instead of rediscovering it.
Route refinement, solvent reduction, yield and purity improvement, scale-dependent parameters identified before they become problems.
Reactors up to 50 L for preclinical and early-phase material, with full analytical documentation.
Particle engineering to meet the size distribution the formulation requires, with form integrity verified after processing.
Process description, analytical methods and know-how packaged for your chosen manufacturing site.
Cytotoxics, ADC payloads, hormones and controlled substances are handled in validated containment to OEB5 (<1 µg/m³), under Ministry-of-Health authorisation and with full chain of custody. Screening, characterisation and processing all happen in-house: the potent steps are never outsourced, and the material never leaves our control.
| Stage | Typical scale | Purpose |
|---|---|---|
| Screening | 10–500 mg | Form discovery and characterisation. |
| Process development | 1–100 g | Crystallisation design, seeding and control strategy. |
| Demonstration | 100 g – 1 kg | Reproducibility, bulk property confirmation. |
| Kilo-lab supply | Up to multi-kg, 50 L reactors | Preclinical and early-phase material, non-GMP. |
The following profiles are representative of typical PCL Research & Manufacturing programmes. Compounds and clients are not identified; scope, duration and deliverables are confirmed for each programme in the applicable quotation.
The engagements described above are representative of typical projects and are presented in anonymised form. Scope, duration and deliverables are agreed for each programme in the applicable quotation and do not constitute a performance guarantee.
Every project is run by the scientists who will do the work, not handed down through account layers. You speak to the people holding the flask.
A conversation with our chemists about the molecule and the problem, under confidentiality, before any proposal is written.
A defined scope with techniques, timeline, deliverables and price. No open-ended time and materials.
Work proceeds with interim updates at agreed points, so findings can redirect the plan while it still matters.
A full technical report with raw data, interpretation and recommendation, followed by a discussion of what to do next.
Compounds, structures and results are segregated by project and never used outside it.
Forms discovered during your programme belong to you, with data packaged to support filing.
Raw data supplied alongside interpretation, traceable through our quality system.
Our authorisations are not a badge on a website: they define what we are allowed to handle, and they are what let a single site cover work that is usually split across several.
Inspected test facility for pharmaceutical analysis, supporting US filings.
Analytical department certified to GMP by the Italian Medicines Agency.
For controlled substances and HPAPI study and production.
| Diffraction | XRPD (ambient and variable temperature/humidity), single crystal XRD, synchrotron access, neutron diffraction, MicroED. |
| Thermal analysis | DSC, modulated DSC, TGA, TGA-IR coupling, hot-stage microscopy. |
| Chromatography | HPLC, UPLC, GC headspace for residual solvents, ion chromatography. |
| Spectroscopy | FT-IR, FT-Raman, solid-state and solution NMR, ICP-MS for elemental impurities. |
| Physical characterisation | DVS, particle size by laser diffraction, SEM, optical microscopy, Karl Fischer. |
| Crystallisation | Automated parallel platforms, jacketed reactors to 50 L, in-situ process monitoring. |
Facility inspection by the FDA refers to an inspection of the site and does not constitute approval, certification or endorsement by the FDA. GMP certification covers the analytical department; CDMO manufacturing is performed under non-GMP conditions with full analytical documentation.
Serving pharmaceutical clients across three continents for over two decades — from emerging biotechs with a single molecule to established manufacturers with commercial products.