Ardena Oss supports pharmaceutical companies worldwide with the development of their innovative products. Ardena Oss has expertise in Active Pharmaceutical Ingredients and nanomedicines. For these innovative products, Ardena Oss develops and validates the manufacturing process and the analytical methods, and performs the cGMP manufacture, quality control, and stability studies.
Ardena Oss’ team has ample experience with the development of novel pharmaceutical products. We help our customers to bring their novel products from research to clinical trials, and to commercialization. We offer more than development and manufacturing services. We provide you with enabling technologies, solutions, and expertise, to get your product to clinical development in the fastest and best possible manner.
Area of work
Active Pharmaceutical Ingredients, Nanomedicines, bulk Drug Products, process & analytical development, cGMP Manufacturing, Quality control, Stability studies
Drug development Pipeline
Pre-clinical development – Clinical Phase III
Services and products
- Decades of experience in bringing new API from discovery to clinic and to registration
- Globally leading company in development and cGMP manufacture of nanomedicines.
- Intimately familiar with all regulatory and quality requirements.
- GMP license for manufacture of API and nanomedicines
- Offers enabling technologies, expertise, and solutions to get your product from lab to clinical studies
ACTIVE PHARMACEUTICAL INGREDIENTS
- Manufacture of APIs for preclinical, clinical, and commercial use.
- State-of-the-art manufacturing facilities suitable for gram to tens of kgs.
- Strong process development skills
- High potent substances such as hormones and cytotoxics.
- Purification technologies including column chromatography, and preparative HPLC, ion exchange chromatography, and ultra- and nanofiltration.
- Experience in iron oxide nanoparticles, polymeric nanoparticles, liposomes
- Design and optimization of nanoparticle products.
- Process development, scale up, and cGMP manufacture
- High temperature processes, batch-wise, and continuous flow processes.
- Purification technologies including TFF and magnetic separations.
- Full analytical support for intermediates, API, and Drug Products.
- Analytical method development and validation
- Release and stability testing
- Identity, purity, assay, residual solvents, and solid state properties of API.
- Testing and characterization of nanoparticles.
- Slow release formulations such as depot formulation
Highly motivated students looking for a place to fulfill their graduation project are welcome to send us an open solicitation.