Parenteral cytotoxic agents are among the most highly sophisticated and sensitive drugs to handle and produce. Utilizing RABS (Restricted Access Barrier System) for commercial manufacturing helps BioPharma Solutions to maintain a high level of containment while a product is being manufactured. In addition, this technology helps to maintain the integrity of the molecule, enhance product sterility and ensure the safety of the line operators.
Dealing with high potency molecules, including antibody-drug conjugates (ADCs), requires a dedicated facility that utilizes experienced operators, sophisticated equipment and systems, and robust standard operating procedures, training and risk assessments.
BioPharma Solutions' facility in Halle/Westfalen, Germany, has multiple manufacturing areas with independent air supply and waste disposal systems, including 100% waste collection. In addition, our Halle and Bielefeld facilities are certified by SafeBridge doing both parenteral drug substance synthesis and parenteral drug product manufacturing and testing.
At our recently expanded cytotoxic contract manufacturing facility in Halle/Westfalen, Germany, all your cytotoxic parenteral needs are handled at one manufacturing facility, which allows us to create efficient processing solutions to fit your compound. A dedicated cytotoxic focus helps manage capacity and flexibility, which are critical for maintaining reliable product supply.
For cytotoxic molecules, we offer the following capabilities:
- Liquid and dry-powder filling
- Clinical- and commercial-scale lyophilizers
- Sterile Crystallization
- Flexible compounding areas
- Disperse Systems
- Formulation and subsequent filling/lyophilization of colloidal drug carriers, e.g. liposomes, micelles, nanoparticles, microemulsions
- Technology portfolio: Homogenization (piston-gap, microfluidization, membrane extrusion), diafiltration, organic solvent distillation, liposome direct and remote loading, sterilizing filtration
Integrated support services for cytotoxics include:
- Technology transfer
- Analytical and microbiological services
- Stability storage
- Packaging and kitting
- Lyophilization cycle development
- Engineering support
- Regulatory support
Proven experience with a variety of molecule classes:
- Antibody-Drug Conjugates (ADCs)
- Small molecules
- Liposomal systems