MANUFACTURING EXPERTISE
In Cell and Gene Therapeutics
MANUFACTURING EXPERTISE
In Cell and Gene Therapeutics
MANUFACTURING EXPERTISE
In Cell and Gene Therapeutics
OPTIMA pharma starts a cooperation with Charité
The Objective is the Development of an Automated Production Process for Cell and Gene Therapeutics
Optima Pharma and Charité – Universitätsmedizin Berlin jointly developed a concept for a production platform with an automated manufacturing and filling process for cell and gene therapeutics. The innovative project is financed by the Berlin Institute of Health (BIH). These new therapeutics pave the way for personalized medicine. They are considered promising new therapy opportunities for hereditary and metabolic diseases, neurodegenerative disorders, and cancer.
These medications are based on the patient’s own cells and are still processed manually for each individual patient, which is very expensive.
These medications are based on the patient’s own cells and are still processed manually for each individual patient, which is very expensive.
“Two experienced partners joined together with Charité and Optima Pharma. Both are equipped with the necessary expertise to develop a future production platform for the cell and gene therapy market.”
Dr. Andrea Traube
Director Market Development Pharma, OPTIMA pharma GmbH
Networking Creates Synergy Effects
OPTIMA pharma Provides Technical Expertise, Charité Contributes Process Knowledge
Know-how in the areas of process engineering
and process technology as well as automation
and process technology as well as automation
Know-how about the production of cell- and gene
therapeutics and control process knowledge
therapeutics and control process knowledge
Optima Pharma is working jointly with Charité on a closed and modular production platform that allows us to automate the production of these therapeutics while maintaining the Good Manufacturing Practice guidelines of the pharmaceutical industry. This production platform offers the opportunity to map the necessary manufacturing processes of different gene and cell therapy products. Charité has the according knowledge in producing these therapeutics. Optima Pharma contributes the necessary expertise in the process technology and automation.
Pilot project with Charité
Design and Development of a Production Platform
The production platform will be based on isolator technology .
This technology increases the process safety and the risk to lose the patient’s individual product is significantly minimized. This is also ensured by the automatic decontamination of all work areas. In addition, all process steps are documented during the entire manufacturing process. Human interference is limited to a minimum, to protect the product, and therefore, minimizes the risk to the patient.
This technology increases the process safety and the risk to lose the patient’s individual product is significantly minimized. This is also ensured by the automatic decontamination of all work areas. In addition, all process steps are documented during the entire manufacturing process. Human interference is limited to a minimum, to protect the product, and therefore, minimizes the risk to the patient.
- High process safety
- Strict separation of operator and product
- Process automation
- Based on proven isolator technology
- Automated documentation of all process steps
