We help you identify optimal solid forms with high- and medium-throughput solid-state services, state-of-the-art analytical techniques and experimental work at different scales.
Science-led. Proven. We craft a route that reduces development risks and time to market
We have an extensive and proven track record in solid-state screening and research studies designed to help you explore the true potential of your molecule.
Our solid-state research team investigates the solid form of your drug substance to identify a stable salt and/or polymorphic form, with acceptable bioavailability and bulk properties. We design crystallization processes that consistently produce your desired form.
A committed project manager is at your side making it easier to identify untapped potential and seize available opportunities. Our reporting format enables our customers to drive stakeholder discussions and strategic decision-making. With a typical time frame of 6-8 weeks from delivery of the material, our screens are tailored to your budget and deadlines.
We are also one of a few companies worldwide that can handle highly potent and controlled substances.
We help you to gain knowledge of your compound’s crystal structure at an atomic level and characterize its intermolecular interactions. This helps us to obtain a wealth of information crucial for absolute configuration (enantiomers), phase identification, quality control, process development and patent protection.
Our crystallography services include X-ray diffraction, which is widely recognized as the most reliable tool for the analysis of pharmaceutical solids and crystal form identification.
Navigating complexity with the scientific expertise of our people, we can solve the crystal structure from X-ray powder diffraction where it’s not possible to obtain a crystal of the drug substance at a suitable size for data collection. We also offer X-ray powder diffraction measurements at ambient conditions and/or at variable temperatures or humidity.
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 solid-state research team has expertise in identifying new crystal forms as well as in 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.q. 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.
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.
We help you walk the smartest path to the clinic by guiding the selection of optimal crystal forms with a series of preformulation studies, including:
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 of a drug substance considerably helps to choose between different drug substance sources.
Increasing drug development costs and greater competition are forcing the pharmaceutical industry to explore the true potential of existing molecules in order to maintain or extend patent protection.
The quest to stretch a molecule’s lifecycle has become at least as important as the discovery and development of new drug candidates.
We leverage solid-state research capabilities to provide insights and techniques to assist with lifecycle management.
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, with over a decade of experience in drafting patents for drug substance solid forms we help customers ensure their molecules are protected in the most effective manner.
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.
Our expert team members share deep, scientific understanding and insights into solid-state screening and research.
Get in touch to see how we can craft your path to the clinic with dedicated capabilities.
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.