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
Spray drying is a continuous, reproducible, cost-effective and scalable process for the production of stable amorphous solid dispersions.
This technology enables the production of dry pharmaceutical powders for tablets, powder-filled capsules and inhaled drug products.
The dispersion of a drug in a polymer matrix results in enhanced solubility in intestinal fluids and improved bioavailability.
To enable rapid product development and file submission it is paramount to integrate CMC strategies and regulatory aspects early in the drug product development process.
CMC demands are growing throughout the clinical phases and they require phase appropriate expertise and management skills.
This webinar will address key CMC challenges and integrated project management solutions for spray dried pharmaceutical product development.
Presenters
Stefano Console
Scientific Advisor
Stefano Console has more than 30 years of experience in the pharmaceutical and fine chemical business. The broad experience gained with different CDMOs coupled with an unceasing scientific curiosity for new technologies led Stefano to hold strategic roles managing a large number of successful projects for big as well as small Pharma partners across EU, USA and Japan. A vibrant passion for business development, organizational innovation and start-up initiatives, together with a relevant expertise in pharmaceutical particle engineering technologies (especially micronization and spray drying related technologies) and respiratory products complete the profile.
Currently Stefano is Senior Advisor and Founder at Oriento SA, Member of the Advisory Board at eu.reca (European Respiratory Cluster of Antwerp) and Scientific Advisor at Ardena.
Stefano received his five-year degree in Chemistry from the University of Milano, Italy.
Arno Vermote
Senior CMC Writer
Graduated in Pharmaceutical Sciences and having obtained a PhD in medicinal chemistry, he started his career as a medical writer for a Belgian CRO. Later he joined Ardena as a CMC Writer and rapidly grew to Senior CMC Writer. His role is to provide regulatory advice to clients as well as to write regulatory documentation for new chemical entities in clinical studies. Next to providing assistance and support to clients, he also fulfills a role in technical sales for the Ardena Dossier Development team. Having a background in medicinal chemistry and being a pharmacist by training, Arno combines knowledge and expertise in both drug substance and drug product development.
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.