The recent article published in American Pharmaceutical Review in Sept/Oct 2019 was written by Kenny McCleary and Jochen Becker and entitled, “Manufacturing of Highly Potent APIs with Best-Practice Safety and Containment Control Procedures” and talked about all the necessary components of a standard potent compound program. The whole paper can be viewed at his link.
In the paper, table 1 covers the key elements utilized at the potent compound facility run by Evonik in Indiana. Common players are toxicologists, industrial hygienists, Quality specialists, operations and engineering. These people combine talents to provide expertise in the manufacturing of highly potent compounds.
What is a highly potent compound? Highly potent APIs are pharmacologically active substances that exhibit biologic activity at extremely low concentrations, such as a daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of <10 μg/m3 as an eight-hour time-weighted average. Approximately one quarter of all new chemical entities and around half of those in clinical development are estimated to be highly potent, with the overall global market for highly potent active pharmaceutical ingredients (HPAPI) expected to increase from $16.5 billion in 2017 to $26.8 billion in 2023 at a growth rate of 8.7%.
Hazards of these HPAPIs need to be determined, understood and controlled in the manufacturing environment or operators will get hurt. Granted, all these chemical products are designed to helpful drugs that can change lives for the better, but there is a dark side to pharmaceuticals. The side effects and the occupational effects. Another fact of the matter is that pharmaceuticals are designed to have an effect on the human body and if an operator provides a pathway of exposure to that drug product, it will have the designed effect. Regulatory and safety requirements of HPAPIs are identified and understood to enable the development of Occupational Exposure Limits (OEL). Together with other factors including Short-Term Exposure Limits (STELs) and the physical properties of an API, the definition of an OEL plus associated health risk classifications enable organizations to conduct risk assessments for operators working in HPAPI facilities. These risks can include various acute, allergenic, corrosive, carcinogenic, mutagenic, toxic, reproductive, and other occupational health hazards.
The toxicologist, like Superior Toxicology & Wellness, provides the service to set the OEL and ADE values for the contract research organization. The toxicologist must act as part of the team of people outline earlier to insure employee safety over all other objectives. Cross contamination is important, product integrity is important, GMP and engineering of containment equipment in the manufacturing environment. Everyone must work together to make sure no one is injured on the job. With the current trend in the industry moving toward even greater levels of highly potent active ingredients, more attention has to be focused on the safety in manufacturing.
Evonik did a great job on the description of their HPAPI facility in Indiana. Superior Toxicology & Wellness can be part of that team and add value to an already good team.
Superior Toxicology & Wellness can provide expertise in evaluating your new drug entities and existing products for all the occupational toxicology needs. The excellent value of Superior Toxicology & Wellness products is complemented by our extremely quick turnaround and first-class customer service.
As always, drop us a line through the contact form with any questions or comments.