Abstract

Increasing numbers of APIs are deemed highly potent, and this poses a challenge for manufacturers. This article looks at what makes an API highly potent, how the hazards are classified, and what practical steps manufacturers must take to ensure the safety of their operators and the environment.

Effective containment is essential for any facility that manufactures highly potent APIs (HPAPIs), especially now as increasing numbers of drug molecules are classified as highly potent. Many of them are anticancer agents, which are either used as the molecule alone, or conjugated to an antibody to target them to an active site on a tumour. But it’s not just oncology products – there are other classes of drugs that are commonly highly potent, such as steroids, vitamin D analogues and many antibiotics. All of these require special care during manufacture.

Such molecules are typically very specific and targeted, and will be active at extremely low doses. This has advantages for patients because they will not need to take as much of the drug to have a therapeutic effect; thus the chances of experiencing side-effects will likely be reduced. In addition, if they are also longer-lasting within the body, they will not have to take the drugs as frequently, which is another major advantage for patients.
However, this does provide significant problems for manufacturers. As the molecules are so potent, it is vital that the operators within the facility ar ...