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.
Antibody-Drug-Conjugates (ADC) have emerged as an efficient technology to deliver cytotoxic drugs into cancerogenic cells. The mechanism is based on an antigen-mediated uptake of a cytotoxic drug conjugated antigen via clathrin-mediated endocytosis and release of the drug after lysosomal cleavage to its intracellular target.
With 14 ADCs currently approved worldwide, ADCs have proven their therapeutic value in increasing efficacy and reducing toxicity especially in oncology. Recent research however has shown that the cytotoxic drug mechanisms, drug-antibody ratio, antibody penetration and processing, resistance and off-target drug effects of ADCs can be further enhanced.
This continues to drive high investments into ADC research and development increasing the demand for external partnerships and expert support.
Translating the drug design concept of an ADC into a final product remains a major challenge. The cytotoxic small molecule drug can covalently bind to the monoclonal antibody at multiple sites during the synthesis leading to a heterogeneous mixture of unfavorable ADC products. In order to move into the preclinical and early clinical phase the exposure-response relationship for efficacy and safety must be established. For IND/IMPD filing, a bioanalytical strategy tailored to each of the ADC components is required by the regulatory authorities.
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.