Process development, analytical development, analysis, stability testing, manufacturing
Crystal structure by X-ray, solid form screening, solid form selection, IP support
Formulation development, analytical development, manufacturing, stability studies
Packaging, labeling, clinical trial logistics
Mass spectrometry, immunochemistry, flow cytometry, in-vitro drug discovery, clinical trial services
Scientific report writing, module 3 writing, regulatory CMC support
Guiding your nanomedicine candidate through its journey to the clinic
Developing and manufacturing formulations that lead to improved bioavailability
Meeting your needs from pre-clinical to small-scale commercial manufacturing
Bringing your oral drug to clinical trials quickly and reliably
Guiding you through the development of injectable drug products to GMP standards
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Helping you turn your compounds that show promise into GMP-grade drug substances.
We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.
Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.
We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.
Always agile, we reliably guide you and your molecule through the challenging terrain of early phase development
Carefully engineered to support and enable early phase development for our partners’ oral drugs, injectables and nanomedicines
Our leadership team has a deep scientific understanding combined with exceptional experience
Platforms and facilities that are uniquely engineered to support and enable integrated early phase development
We’re a fast-growing EU-based company with many opportunities for you to grow and progress with us
The search for a stable polymorph of your drug substance (DS) is a key component of your drug development program. Polymorphs are crystalline materials that have the same chemical composition but different molecular packing. Different polymorphs may differ greatly in terms of solubility, dissolution, hygroscopicity, hardness, compressibility or flow properties.
Poor understanding of DS solid-state properties may lead to unintended and unnoticed solid form conversions during processing or storage, and ultimately affect manufacturability, bioavailability and clinical outcome. Another commonly encountered problem is the use of different polymorphic forms during clinical development, which may require bridging studies to demonstrate to the regulatory authorities that the clinical trial results are valid. It is therefore essential to study DS solid-state properties sooner rather than later. However, discharging more risk than necessary by conducting extensive screens too early can add up to substantial unwarranted costs. Many of our customers struggle with this dilemma, and we often get the question: “When should we invest in a solid-state screening program?”.
Please fill out the form to unlock the rest of the content.
Our team members share deep, scientific understanding and insights into their respective fields of expertise.
Sign up to receive drug development insights, the latest on industry trends & Ardena news.