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.
Case study: Building discriminatory power into dissolution testing in late development – a key milestone for the fast product approval
Dissolution testing was introduced into pharmaceutical practice after the occurrence of serious side effects of phenytoin after calcium sulfate was replaced by lactose. As a result, the FDA introduced the USP Dissolution type 1 (Basket method) test as a QC test in 1971 followed by USP Dissolution type 2 (Paddle method) test in 1978. Over the years, FDA developed further guidance to advance in-vitro dissolution testing into an important tool for development, quality control and drug approval. Statistical methods were implemented to compare the similarity or dissimilarity between two dissolution profiles, bio-relevant media were requested for predicting IVIVC and more specific guidelines were release for immediate and modified release products as well as the solubility and permeability characteristics of the drugs according to the BCS drug classification. With the growing knowledge on biopharmaceutics and predictive in-silico tools, dissolution testing has evolved into a key element for drug development and regulatory assessments. This includes that the dissolution test method has to include clinically relevant dissolution specification and must have proven discriminating power between variations outside the acceptance criteria.
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.