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.
Agile and reliable, we guide you and your molecule through the complexities of drug development.
A legacy of scientific excellence, development expertise and integrated solutions.
Seven GMP/GLP facilities across Europe and the US, supporting innovation.
Guided by experienced industry leaders, our Board ensures strategic direction and excellence.
An international and diverse team of scientific and industry experts driving our progress and success.
A dynamic, passionate, and growing team with opportunities to learn and make an impact.
This whitepaper explores Ardena’s strategic methodology for addressing the challenges in synthesizing highly potent compounds (HPAPI) during early drug development. Emphasizing a rational risk-based approach, the paper outlines key factors in achieving safety, efficiency, and compliance with regulatory standards. The methodology includes continuous risk assessment, facility design based on Occupational Exposure Bands (OEB), and a phased strategy for drug synthesis. With a focus on Quality by Design (QbD) principles, the approach ensures scalability and optimization, allowing for rapid adaptation as more safety data become available. This methodology positions organizations for success in drug development, providing an integrated platform for synthesis and manufacturing from pre-clinical to clinical stages.
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