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
Enhancing biomolecule purity with tailored solutions for GMP-grade materials at scale
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
Scaling up the synthesis process of new chemical entities may require the use of hazardous reaction conditions or reagents. It is essential to develop a thorough understanding of the chemistry involved to prevent unsafe situations.
At Ardena, we design synthesis processes that are intrinsically safe. During the proposal preparation process, we identify hazardous chemical transformations and reagents. We inform our customer on potential safety issues and propose alternative reaction conditions and/or reagents during the project chartering phase. During process development, all chemical reactions are thoroughly assessed for hazards.
Many accidents in chemical plants are caused by poorly controlled heat-releasing (exothermic) reactions. It is therefore critical to know the energy content of each reaction and to develop chemical processes in such a way that exothermic reactions are controllable or dose-controlled and thus stoppable at any point during processing.
Our internal governance at Ardena ensures that such exothermic events are properly assessed via tools such as reaction calorimetry and differential scanning calorimetry. Reaction calorimetry is a well-established technique to determine the thermal profile of a reaction and its associated temperature change, whereas differential scanning calorimetry analysis is used to identify the onset temperature of hazardous events.
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