Piramal Pharma Solutions in Riverview has invested about $10 million in a new wing dedicated to the production of high-potency active pharmaceutical ingredients with low occupational exposure levels. The company is a contract development and manufacturing organization and based in Kentucky.
“This new, enhanced capability opens the site up to a new base of customers, including the antibody drug conjugate (ADC) market,” says Vince Ammoscato, vice president and head of the Riverview site. “We are equipped to offer ADC customers a seamless end-to-end solution, since we can develop the HPAPI payloads and linkers here in Riverview, send them to our site in Scotland for the antibody conjugation, then back to our Lexington, Ky. site for sterile fill and finish.”
The upgrade includes a new quality control/analytical lab and two kilo-labs, as well as the doubling of the office space to support the Riverview site’s growth. The new wing was designed with the required engineering controls and containment solutions to handle high potency active pharmaceutical ingredients with occupational exposure levels <1mcg/m3 and as low as ~20ng/m3. Materials in the new wing will primarily be produced at kilo-lab scales.
“We are one of only a few companies in the contract development and manufacturing market that have the capability to produce HPAPIs at such low OELs,” says Vivek Sharma, CEO of Piramal. “It’s another example of how we remain committed to partnering with our customers to serve the patient community and reduce the burden of disease.”
The local staff has increased from 80 to 127 people and has a projected total of about 150 employees in the near future. This includes scientists with bachelor’s and doctorate degrees as well as manufacturing operators and other skilled workers.
More expansions are forthcoming, says Ammoscato. There is space at the site for added capacity and new capability enhancements that will be designed to match the market needs of the pharmaceutical industry.
Piramal offers end-to-end development and manufacturing solutions across the drug life cycle. It has facilities in North America, Europe, and Asia.