Join Alcami for a webinar to learn more about the design approach to highly potent active pharmaceutical ingredient (HPAPI) suite design in a multi-use facility.
As new drug targets naturally become more potent in the search for more effective therapeutics, there is a growing demand for capacity and capabilities in support. The development and manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPI) in a multi-use facility faces challenges of technical, procedural and a perception-based nature. Fundamentally, it all starts with the use of the right tool for the job.
This webinar will focus on the risk-based approach to facility and equipment design when faced with the unique challenges of being a Contract Development and Manufacturing Organization (CDMO):
- User requirement specification development
- Containment strategy risk assessment
- Process hazard analysis
- Flexible and expandable design
- Validation strategy
- Product changeover