The nature of cytotoxic products requires them to be treated with extreme caution. The safe and responsible handling of cytotoxic drugs requires:
- Avoidance of cross contamination with any other products under development or in production
- Measures to protect staff that are significantly more stringent than normal lab practices
- Clear and exacting operating procedures to avoid accidents, spillages etc
- Appropriate precautions for dealing with and disposing of laboratory waste
For these reasons the number of development partners open to advancing therapies in this field is limited.
Your Partner for Cytotoxic Development
Biopharma Technology is able to offer an exceptional combination of safe processing with a world-wide reputation for lyophilization. With a standalone laboratory and dedicated equipment we are pleased to offer a complete lyophilization R&D package for cytotoxic products. This provides an outsourcing capability for smaller developers and specific product development expertise for more established enterprises. By choosing BTL as a cytotoxic partner, clients can have the confidence in Biopharma’s lyophilization expertise and confidence that their product will be processed in a safe and controlled working environment.
Our Cytotoxic Laboratory
Biopharma’s dedicated cytotoxic handling facility has been built to Class 7 standards and offers exemplary containment and safety features. The suite contains a full range of characterization and analysis equipment as well as a 0.56m2 pilot-scale freeze dryer. This enables us to provide product and process development services and small scale production runs.
The Benefits of Biopharma Technology’s Approach
- Dedicated standalone laboratory designed for handling cytotoxic and combination therapies
- Development of products and processes for freeze drying
- Small-scale production runs for concept and stability testing and trials
- Extensive expertise in freeze drying a variety of products
- Formulations and cycles designed to best suit the needs of each individual product
- Optimized solutions for cost-efficient processing – essential for generic therapies
- Product Characterization
- Formulation Development
- Cycle Development
- Process Scale-Up and Optimization
- Small-Scale Production
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