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
Drug discovery and the scale-up of newly developed manufacturing processes represent an exciting and dynamic field for academic scientists, startups, and small to large pharmaceutical companies. The scale-up to clinical batch sizes, in particular, poses challenges as lab-scale manufacturing expands to batch sizes in the multi-kg range, requiring further optimization of manufacturing processes. Due to the limited and often unknown safety profiles of new compounds, this scale-up is conducted in specialized facilities equipped with adequate contingency measures.
To ensure patient safety, a key issue in the manufacture of active pharmaceutical ingredients (APIs) in multi-purpose, multi-product manufacturing equipment is the adequate management of potential (cross-)contamination, especially when the product portfolio includes both developmental and commercial manufacturing processes.
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