Oncotec Pharma Production
Oncotec Pharma Produktion GmbH is a reliable global partner in the manufacturing and development of aseptically produced cytostatics made in Germany. The company offers full-service solutions from development to market launch and commercial production, utilizing state-of-the-art technology and adhering to strict international standards. With a focus on quality, innovation, and customer collaboration, Oncotec aims to provide high-quality pharmaceutical manufacturing services and support the entire value chain of pharmaceutical products. Since its founding in 1997, Oncotec has continuously expanded its capacities, modernized its facilities, and invested in new technologies, including lyophilization systems and advanced filling lines for vials and syringes, to meet growing global demand and ensure compliance with international quality standards.
Industries
Nr. of Employees
large (251-1000)
Oncotec Pharma Production
Dessau, Sachsen-Anhalt, Germany, Europe
Services
On-site contract manufacturing of aseptic liquid products (vials and prefilled syringes) including clinical and commercial batch production, integrated inspection and secondary packaging for market supply.
Feasibility studies, formulation optimisation, development and optimisation of lyophilization cycles, and scale-up support from laboratory through pilot to commercial manufacturing, including process validation support.
Analytical method development, method transfer and validation, forced-degradation studies and stability testing in accordance with ICH guidance, plus support for CTD preparation and market authorisation activities.
Small- and large-scale fill-finish lines integrated with lyophilization workflows designed to support development and manufacture of antibody-drug conjugates and other complex cytotoxic products, including clinical supply production.
Access to laboratory and pilot-scale equipment including lab freeze-dryers and small clinical-scale filling lines to support early development, sample generation and hands-on process optimisation.
On-site contract manufacturing of aseptic liquid products (vials and prefilled syringes) including clinical and commercial batch production, integrated inspection and secondary packaging for market supply.
Feasibility studies, formulation optimisation, development and optimisation of lyophilization cycles, and scale-up support from laboratory through pilot to commercial manufacturing, including process validation support.
Analytical method development, method transfer and validation, forced-degradation studies and stability testing in accordance with ICH guidance, plus support for CTD preparation and market authorisation activities.
Small- and large-scale fill-finish lines integrated with lyophilization workflows designed to support development and manufacture of antibody-drug conjugates and other complex cytotoxic products, including clinical supply production.
Access to laboratory and pilot-scale equipment including lab freeze-dryers and small clinical-scale filling lines to support early development, sample generation and hands-on process optimisation.
Expertise Areas
- Aseptic sterile fill-finish for vials and prefilled syringes
- High-throughput industrial filling lines
- Lyophilization and freeze-drying cycle development (lab to production)
- Analytical method development, transfer and validation
Key Technologies
- Isolator-based aseptic filling
- Lyophilization (freeze-drying) — lab, pilot and production scale
- Automated visual inspection systems for vials and syringes
- Robot-assisted filling and automation
News & Updates
Oncotec participates in the 2024 apprenticeship offensive on October 26, 2024, from 10-13 hours.
Participation in the Returners' Day on December 27, 2024, in Dessau.
Various events where Oncotec can be met.
Oncotec participates in the 2024 apprenticeship offensive on October 26, 2024, from 10-13 hours.
Participation in the Returners' Day on December 27, 2024, in Dessau.
Various events where Oncotec can be met.