We know solid state
We identify optimal solid forms using high and medium-throughput screening, state-of-the-art analytical techniques, and 25+ years of solid-state expertise – integrated directly with drug substance manufacturing on the same site.
De-Risking the Development of your molecule
We bring a proven track record of 25+ years in solid-state screening and research, helping you unlock the full potential of your molecule and de-risk the development process. Our experienced solid-state team systematically investigates drug substance and drug product properties to identify the optimal phase-appropiate polymorph, salt or co-crystal form that balances stability, bioavailability, and manufacturability. Our crystallization process development capabilities are designed to reliably deliver your target form, ensuring consistency and scalability.
Throughout your project, a dedicated project manager provides clear guidance and seamless communication, helping you uncover opportunities and make informed decisions at every stage.With a typical turnaround time of 6–8 weeks from receipt of material, our screening programs are fully aligned with your timelines and budget.
In addition, we are among the few organizations worldwide equipped to safely handle highly potent and controlled substances.
Crystallization process development
We support you in designing and optimizing crystallization processes that consistently deliver the desired solid form with high yield and exceptional purity
Subject Matter Experts
René Steendam
Director of Solid State Research
René Steendam is Director of Solid State Research at Ardena. He combines technical expertise in solid-state chemistry with experience in project management and business development across pharmaceutical development programs. Throughout his career, René has worked across both academia and industry, contributing to global pharmaceutical development projects with a focus on crystallization and solid-form development. He has authored more than 20 scientific publications and currently serves as Chairman of the Dutch Association for Crystal Growth (DACG). René obtained his PhD in Solid-State Organic Chemistry, specializing in crystallization and solid-form development.
Paul van Tilborg
Director of CRO Services
Paul van Tilborg is a senior scientific and operational leader with over 25 years of experience in analytical sciences, CMC development, and CRO operations. As Director CRO Services at Ardena in Oss, he is responsible for building and scaling bioanalytical capabilities and leading solid-state research activities, while contributing at an executive level to API analytical sciences. Paul has a strong track record in developing organisations, facilities, and teams with a clear focus on operational efficiency, customer value, and financial performance. At Ardena, he transformed the analytical sciences function from a small start-up operation into a fully established department supporting multiple development programmes, combining technical capability build-up with scalable, financially robust operations. He consistently drives growth by aligning scientific excellence with client needs, ensuring reliable delivery, transparency, and long-term partnerships. His approach emphasises fit-for-purpose solutions, efficient execution, and creating measurable value for customers and the organisation. Earlier in his career at MSD (Organon/Schering-Plough), he led analytical development teams and contributed to CMC strategies, regulatory submissions, and the delivery of complex drug development programmes. He holds a PhD in Chemistry from Utrecht University and contributes to postgraduate education through teaching in applied NMR spectroscopy.
Giovanna Brancatelli
Principal Scientist and Scientific Director
Giovanna Brancatelli is Principal Scientist and Scientific Director at Ardena Solid State Research in Oss. She supervises R&D projects focused on polymorph, salt, and co-crystal screening, as well as preformulation studies supporting pharmaceutical development programs. Giovanna joined Ardena in 2015 from the Department of Chemistry at the University of Trieste, where she conducted postdoctoral research on the molecular recognition of biogenic amines in the solid state. Her expertise includes polymorphism, crystallization, organic and inorganic chemistry, supramolecular chemistry, and X-ray crystallography. Giovanna earned her MSc degree and PhD in Chemical Sciences from the University of Messina.
Peter van Hoof
Group Lead Solid State Research
Peter van Hoof is Responsible Group Lead and Project Leader for Solid State Research at Ardena. He leads the scientists in the solid-state laboratory and oversees the scientific direction of customer projects supporting pharmaceutical development programs. Peter has worked in the pharmaceutical industry since 1998 as a solid-state expert, with a strong focus on the CMC development trajectory of newly developed APIs. Throughout his career, he has supported a broad range of drug development programs, building extensive expertise in solid-state characterization, crystallization, and pharmaceutical development. He has also co-authored more than 20 scientific publications in the field. Peter obtained his PhD in Solid-State Chemistry, specializing in crystallization and solid-form development.
María Jesús Martín
Senior Scientist and Group Leader
María Jesús Martín is Senior Scientist and Group Leader in the Solid-State Department at Ardena Oss. She combines scientific expertise in solid-state science with project management experience across pharmaceutical development environments. Before joining Ardena in 2022, María Jesús began her career in solid-state science at Pharmorphix in Cambridge and later moved into project management roles within the pharmaceutical industry. At Ardena, she combines her scientific and project management background to support Solid-State Department activities and customer projects. María Jesús studied Chemistry in Zaragoza, Spain, and completed her MChem studies in Edinburgh, United Kingdom.
01
Screening
Solid Form Screening
Solid form screening — including salt, polymorph, co-crystal, diastereomeric salt, conglomerate and amorphous solid dispersions — is vital for successful pharmaceutical development.
With an increase in molecule size and complexity, companies face a larger number of compounds that are either poorly soluble, difficult to crystallize or problematic with respect to desired physical-chemical properties. Our team has expertise in identifying new crystal forms as well as solving problems related to polymorphism and crystallization.
Physicochemical properties of drug substances, such as solubility, dissolution rate and physicochemical stability can be altered significantly by salt formation. Consequently, important properties of the drug product such as bioavailability and shelf life can be radically influenced. Our crystallization platform accommodates high-throughput salt screening studies using only minimal amounts of drug substance. Salt screening is used for both early phase salt selection studies and broad patent protection.
The therapeutic effect of a drug substance is typically dependent on its chirality. Legislation as well as an increased understanding of the molecular interactions between small molecules and their biological targets have shown a rise in the number of single enantiomeric drugs being launched on the market. Acquiring an enantiopure product from a racemic mixture is a challenge because enantiomers have identical physico-chemical properties. Our conglomerate screening capabilities help to identify potential solid form candidates which enable efficient chiral resolution by crystallization. In combination with solution-phase racemization, the target chiral solid form can be isolated with an unprecedented high yield. Our high-throughput salt-screening services furthermore enable the identification of diastereomeric salt forms of a drug substance which allow efficient chiral resolution through crystallization.
The ability of a drug substance to form a co-crystal depends on a range of variables, with the most important being the number of H-bonding donors or acceptors and its steric properties. By systematically exploring the combination of relevant variables, we increase the chance of discovering a co-crystal with the desired properties. Our in-depth crystallization expertise, rational design of experiments and proprietary high-throughput technologies, mean we can successfully identify and characterize co-crystals.
Regulators require that companies fully characterize the polymorphs of their drug substances and checked for polymorph interconversions that can impact therapeutic performance. Due to the unpredictable behavior of polymorphs and their different physicochemical properties, companies also have to demonstrate consistency in manufacturing between batches of the same product. Our unique polymorph screening methodology enhances the understanding of the polymorphic behavior of drug candidates. The scope and size of studies range from small screens for the initial indication of polymorphism to large screens for intellectual property use. Our polymorph screening services use proprietary high-throughput crystallization technology, with the capability to perform more than 1000 screening experiments using only a few grams of drug substance.
Using the amorphous form of a drug substance offers several advantages in terms of dissolution rate and solubility. However, reduced chemical stability, increased hygroscopicity and physical instability are the major drawbacks of using the amorphous phase in the final drug product. This creates the need to stabilise the amorphous phase of the drug substance in a polymer matrix, e.g. an amorphous solid dispersion. A variety of factors contribute to the formation of a suitable Amorphous Solid Dispersion (ASD), including the nature of the polymer, the drug-polymer ratio, the impact of surfactants and the solvent used in the process. We have developed high-throughput solid dispersion screening technology to find the optimal combination of these factors.
Our comprehensive screening programs are designed to obtain the whole range of solid forms of drug substances (polymorphs — including solvates and hydrates, salts, co-crystals and amorphous solid dispersions). By combining experimental design expertise, high- and medium-throughput screening and chemometric analysis with state-of-the-art analytical techniques our screens provide the best chance of success.
Intellectual Property (IP) of the relevant solid forms is vital to defend innovator patents. Our thorough screening techniques ensure identification and characterization of the solid form landscape of a drug substance, as well as detection of potential patent infringement. Additionally, additionally, with over two decades of experience in drafting patents for drug substance solid forms we help customers ensure their molecules are protected in the most effective manner.
02
Selection
Solid Form Selection
The selection of a suitable solid form is a vital step in drug substance development. Solid forms determine bioavailability, solubility, dissolution rate, stability and manufacturability.
The route of application and the intended daily dose play an important role within solid form selection. For example, the solid-state property requirements depend on whether an oral, parenteral, transdermal or inhalation route is the desired method of administration.
03
Crystal Structure
Crystal Structure Determination
We help you gain knowledge of your compound’s crystal structure at an atomic level and characterize its intermolecular interactions. This helps us to obtain crucial information for absolute configuration, phase identification, quality control, process development and patent protection.
Our crystallography services include X-ray diffraction and electron diffraction, widely recognized as the most reliable tools for the analysis of pharmaceutical solids and crystal form identification.
We can solve the crystal structure from X-ray powder diffraction where it’s not possible to obtain a crystal at a suitable size for single crystal diffraction. We also offer measurements at ambient conditions and/or at variable temperatures or humidity.
04
Sourcing
Drug Substance Sourcing
Pharmaceutical companies that outsource drug substance manufacturing can have the option to acquire their drug substance from different sources.
Many important physico-chemical properties of drug substances remain typically unreported upon release which could lead to unexpected issues in downstream processes or in the final drug product.
Our broad analytical capabilities provide a complete understanding of the solid-state identity of drug substances and enable a thorough comparison of drug substances between different suppliers. Insight into solid-state properties including polymorphic form, hygroscopicity and particle size distribution considerably helps to choose between different drug substance sources.
Our studies include
- Solubility and dissolution rate in aqueous media and simulated body fluids at various pH values
- Solubility in organic (pharmaceutically relevant) solvents
- Hygroscopicity evaluation
- Thermal characterization
- Determination of partition coefficients
- Determination of pKa
- Drug-excipient compatibility
- Particle size distribution
05
Preformulation
Preformulation Studies
We help you walk the smartest path to the clinic by guiding the selection of optimal crystal forms with a comprehensive series of preformulation studies.
06
IP Support
Intellectual Property Support
In cases of substandard and counterfeit medicines, investigation of the solid form of the drug substance, or any of the ingredients of the formulation, is essential and may reveal differences in quality or even violation of IP. We use our analytical equipment to characterize the solid-state of the drug substance or excipients of both the genuine and suspicious products in order to pinpoint the differences.
07
Crystallization process development
Crystal Structure Determination
Our solid-state research laboratory is fully integrated within the drug substance manufacturing site and equipped to develop robust, reproducible crystallization processes. We establish phase diagrams and identify optimal crystallization conditions through systematic screening, before scaling the process to larger production volumes. Leveraging advanced technologies, we address common challenges — such as poor filtration — through approaches like spherical agglomeration. The resulting crystallization processes are designed for seamless implementation under GMP conditions.
Small Molecule Development
End-to-end development for small molecules with complex profiles — poorly soluble compounds, highly potent APIs, controlled substances, and challenging physicochemical characteristics. Our scientists know where the problems hide and how to get ahead of them. From first formulation to GMP batch, your program stays in expert hands.
Discuss Your ProgramLarge Molecule Development
Sterile drug product development and manufacturing for biologics and complex parenteral formulations. Our teams are experienced with the sensitivity and precision these molecules demand – from formulation design through aseptic fill-finish and lyophilization. One team that stays with your program.
Discuss Your ProgramNanomedicine Development
Ardena operates one of Europe's broadest nanomedicine platforms – lipid nanoparticles, polymeric nanoparticles, liposomes, nanosuspensions, and beyond. From building block synthesis through GMP production and regulatory submission, we cover the full development arc for nanoparticle-based therapeutics.
Discuss Your ProgramRelated Resources
Our expert team members share deep, scientific understanding and insights into solid-state screening and research.
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Application Note
Informatics-Supported Solid Form Selection
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Application Note
Mechanochemistry-Enabled Solid-State Stress Testing
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Application Note
Precision Polymorph Screening with Electron Diffraction
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Insights
Chirality in drug development: from racemic mixtures to enantiopure substances
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Expert Q&A
Insights into Thermogravimetric and Evolved Gas Analysis
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Insights
The importance of polymorph screenings
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Whitepapers
Solid State Chemistry and Strategic Outsourcing
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Expert Q&A
Design of Experiments (DoE) and its relevance in API crystallization process development
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Expert Q&A
Dynamic Vapor Sorption (DVS) and its relevance in API characterization
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