Performing environmental testing early in a molecule’s development and including data in tech transfers to CMOs helps ensure there is little mass loading from pilot and commercial plants.
Data from environmental assessment of molecules in early Phase I support informed waste handling decisions as production is scaled up. Including the data in technology transfers to contract manufacturing organisations (CMO) helps partners adhere to the same standards.
Speaking at AAPS 2010 Keith Silverman, director at the global safety and environment unit of Merck & Co, said this is how his company operates. Merck tests 10 to 20 compounds a year, said Silverman, with the number depending on how aggressively it is expanding into new markets.
In 2006 the Merck plant in West Point, Pennsylvania, US improperly released potassium thiocyanate into the sewer system. Merck paid a $20m (€15.4m) settlement. Since then Merck has upgraded the plant, the latest phase of which is a proposed sewer line to prevent overflows.
These steps are intended to minimise release of pharmaceutical compounds into the environment. However, Silverman said manufacturing is responsible for relatively little mass loading of chemicals into the environment, with normal patient use being the primary pathway.
Furthermore, water can contain pharmaceutical compounds without it necessarily posing a risk to humans or the environment, said Silverman. Consequently, a scientific approach must be taken to evaluate the risk posed by contaminants.
Canadian environmental policy
Silverman said Canada has developed scientifically justifiable and transparent environmental risk assessment requirements that meet the needs of all stakeholders. An Environment Assessment Working Group was created to develop the policy and has unanimously approved the framework.
In the Canadian model environmental risk assessment is tied to the drug development process with acceptability criteria being based on science. Research into environmental risk increased rapidly over the past 10 years, said Silverman, and this can be used to support policy decisions.