Pharmaceutical R&D is focusing on developing ever more specialized drugs, resulting in increasingly more potent APIs. Therefore, the demand for highly potency drug product manufacturing has been steadily increasing over the years and this trend is expected to continue. With this need comes the importance of various handling procedures, safety controls, and OEL protection. Executing an efficient and optimal highly potent strategy early on can set a strong foundation when it comes time to scale up the manufacture of the highly potent drug product.
During this session, you will learn from industry experts about:
- Highly potent drug product challenges and strategies from early development to commercialization
- Small-scale and large-scale equipment (non-GMP)
- Overview of industry standards and beyond
- OEL containment and safeguard of facilities, engineering controls, personnel
- Segregation of manufacturing areas
- Case Studies