Piramal expands high potency API facility in Michigan
Contract development and manufacturing organisation (CDMO), Piramal Pharma Solutions announced the completion of the expansion at its Riverview, US, site that is dedicated to the production of highly potent active pharmaceutical ingredients (HPAPIs) with low occupational exposure levels (OELs).
The $10m (€8.78m) investment includes a new QC/analytical lab and two kilo-labs, as well as a doubling of the office space, which was needed to support the ‘dramatic growth’ at the Riverview site, the company stated.
The company continued to note that the expansion ‘brings more to the table’ for the site, which has the containment capability and engineering controls to safely handle HPAPIs with OELs <1mcg/m3 and as low as ~20ng/m3.
Materials will primarily be produced in a new wing at kilo-lab scales, while lots of <5 kilos can also be produced at this new facility.
“We are one of only a few companies in the CDMO market that have the capability to produce HPAPIs at such low OELs,” said the company’s CEO, Vivek Sharma.
The site will operate twelve hours-a-day, seven days-a-week and the company plans to fully convert it into a 24/7 site.
In addition, the site’s staff numbers have increased from 80 to 127 people, with a projected total of approximately 150 employees in the near future.
Vince Ammoscato, head of the Riverview site, said that, after the expansion, the site is also opened up to 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,” he explained.
This will allow the company to offer an integrated solution for the ADC market – from proof-of-concept studies to conjugation development, clinical and commercial ADC good manufacturing practice (GMP) batch manufacturing and fill/finish.
Ammoscato noted that the company has plans on more expansions, as there is additional real estate available on the site for added capacity and new capability enhancements.
