Aidan Walker, president of Piramal’s formulation services, told BioPharma-Reporter.com that a number of the Scotland-based company’s clients are “heading towards either accelerated approval or going into Phase III, so our investment is to mirror that trend in the marketplace and to handle increased demand.”
The upgrade will allow Piramal to provide two commercial grade ADC suites at the Grangemouth facility, while retaining clinical phase manufacturing capacity in other suites on site. Walker said the company only manufactures one other small API (active pharmaceutical ingredient) at the facility, which was inspected by the US FDA as recently as last month.
“A number of companies are expecting spectacular results in Phase II trials and may completely miss Phase III studies and move into commercial validation, so that’s an opportunity for us,” Walker said. “And other customers looking to move into Phase III and want their materials manufactured in areas that would support commercial quantities.”
Piramal also intends to expand its proof-of-concept offer at the site for biopharma companies looking to demonstrate antibody and/or toxin suitability for use as an ADC.
Walker added: “I think we see this as phase one of what would be a two or three step investment [at the facility] over the next five years, depending on the success of the molecules and the indications as some clients are in small disease categories so volumes are small.”
In addition to the new suite, Piramal will make other infrastructure upgrades, such as cleaning and buffer prep areas currently unavailable, Walker said. The batch size offered from the Grangemouth, Scotland, facility ranges from 1-1.5kg and Piramal has capacity for further expansion on site if necessary.
As far as the difficulty of manufacturing the ADCs, Walker noted that the facility has to accommodate an “unusual environment” because it has “to be able to handle cytotoxic compounds and be able to protect employees from the compounds…The chemistry itself has its nuances and isn’t entirely straightforward, though it might not be as complex some other synthetic chemistry,” he said.