VxP Pharma specializes in the development and cGMP production of highly potent and cytotoxic drug products under strict closed-system guidelines. Please contact us for details on our equipment and procedures.
Benefits of closed-system manufacturing include:
- Minimized contamination risks
- High-quality product development and manufacturing
- Employee and environmental safety
Cytotoxic agents are among the most highly sophisticated and sensitive drugs to handle and produce. Barrier technology ensures your cytotoxic product is manufactured under precisely controlled conditions by employing state-of-the-art mobile isolator technology in the manufacturing facility to provide an effective physical barrier that protects staff from toxic substances and encloses your product in a sterile Grade A (ISO 5) environment. Similar fixed and disposable isolators can also be utilized to mimic manufacturing operations and enable formulation and analytical development on toxic substances.
Through the use of high containment glove box technology the scientists can create and maintain a controlled sterile environment that enables us to process potent drug compounds including:
- Other acutely toxic substances
Additionally, VxP Pharma can assist our clients in evaluating the hazards associated with their compounds through the valuable new product assessment program to determine an Occupational Exposure Limit (OEL). The OEL value is used to establish cleaning and containment strategies for the drug during manufacturing operations. The operating systems require that all direct product contact equipment is either dedicated or disposable in order to provide robust protection against cross-contamination.
For cytotoxics, we offer the following capabilities:
- API and Drug Product Manufacture
- Clinical- and commercial-scale lyophilizers
- Sterile Crystallization
- Lyophilization cycle development
- Antibody-Drug Conjugates (ADCs)
Integrated support services for cytotoxics include:
- Stability storage, validation and documentation
- Technology transfer
- Analytical and microbiological services
- Packaging and kitting
All areas of the aseptic processing facility are routinely monitored for viable and non-viable contamination via airborne and surface methods by the QC Microbiology Laboratory. Additional support is also included by the full service Analytical Chemistry Laboratory and Quality Assurance Department.