Piramal Pharma Solutions (PPS) has opened a new wing at its Riverview site dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low Occupational Exposure Levels (OELs). The total investment to upgrade the site was approximately $10 million and includes the new QC/analytical lab and two kilo-labs, as well as a doubling of the office space to support the growth at the Riverview site.  
 
To date, the Riverview site has had the containment capability and engineering controls to safely handle HPAPIs with OELs down to 1mcg/m3, at scales ranging from grams to ~250 kilos. The new wing, which consists of two kilo-labs and a QC/analytical lab, expands capacity. It was designed with the required engineering controls and containment solutions to handle HPAPIs with OELs <1mcg/m³ and as low as ~20ng/m³. Materials will primarily be produced in this new wing at kilo-lab scales; lots of <5 kilos can be produced in this new facility.
 
Vivek Sharma, chief executive officer, Piramal Pharma Solutions said, “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. 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.”
 
Vince Ammoscato, vice president and Riverview Site Head, added, “This new, enhanced capability opens the site up to a new base of customers, including the antibody drug conjugate (ADC) market. 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, Kentucky site for sterile fill and finish.”