Exploring Manufacturing and Market Trends in Highly Potent Compounds
In this episode, two Lonza experts, Managing Toxicologist Selene Araya and Charles Johnson, the Senior Director of Small Molecule Commercial Development, delve into the manufacturing process, trends, and future of highly potent compounds.
In the world of pharmaceuticals, some molecules possess an extraordinary level of potency. Known as highly potent compounds or HPAPIs, these substances have the remarkable ability to elicit a biological response in our bodies even at incredibly low doses—and they may even be the future of sustainable pharmaceuticals. Their potency enables targeted treatment of specific cell populations and often offers cost advantages in manufacturing. However, the production of highly potent compounds can create dangerous reactions and therefore comes with inherent risks for scientists and manufacturing personnel.
In this wide-ranging conversation about these powerful molecules, two in-house experts explore Lonza’s facilities and proficiency for the production of highly potent compounds, as well as the advantages of HPAPIs in different therapies. With Lonza’s extensive operating range, new safety challenges come up at each phase, whether it be small-scale lab operations or large-scale multi-ton batch manufacturing. Systematic approaches to protective measures ensure the safety of the staff, making sure to anticipate risks well in advance, and only relying on protective equipment as a last resort.
Curious to Know More?
Join us on this podcast episode as we explore the power and potential of highly potent compounds, delve into the challenges faced in their manufacturing, and envision a future where these compounds shape the landscape of sustainable pharmaceuticals.
KEY TERMS:
Highly Potent Active Pharmaceutical Ingredients (HPAPIs) are compounds used in the production of drugs that have high potency and therefore require special handling and containment due to their toxicity and potential adverse effects.
The STOP principle is an acronym that stands for Substitution, Technical measures, Organizational measures, and Personal Protective Equipment. It defines a hierarchy of protective measures to be implemented in the workplace, with personal protective equipment being the last resort when other measures are neither feasible nor effective.
Engineering controls are measures and systems implemented in the manufacturing process to minimize the potential for exposure to hazardous substances, such as HPAPIs. They include technologies, equipment design, and process modifications that help protect workers.
Personal Protective Equipment (PPE) is specialized gear and clothing worn by workers to protect themselves from potential hazards in the workplace. PPE is considered the last line of defense and should only be relied on when other control measures are insufficient.
Containment refers to the measures taken to confine and control highly potent compounds within the manufacturing process. Containment aims to minimize the release and exposure of these substances to ensure the safety of workers and the environment. It involves various engineering controls, procedures, and equipment to prevent contamination and maintain a safe working environment.