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The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.
On June 20, 2019, contract development and manufacturing organization Piramal Pharma Solutions announced the opening of a new wing at its Riverview, MI, site, into which the company has invested $10 million to upgrade. The new wing is dedicated to the production of high-potency APIs (HPAPIs) with low occupational exposure levels (OELs).
The upgrade includes a new quality control (QC)/analytical lab and two kilo-labs in addition to a doubling of the office space to support 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, with its two kilo-labs and QC/analytical lab, strengthens the company’s position in this area. The new wing is 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, and significant amounts of <5 kilos can also be produced.
“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,” said Vivek Sharma, CEO, Piramal Pharma Solutions, in a company press release.
“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, KY, site for sterile fill/finish,” added Vince Ammoscato, vice-president and Riverview site head, in the press release.
More expansions are forthcoming, and additional real estate is available on the site for added capacity and new capability enhancements, according to Ammoscato.
Historically, the Riverview site operated as one shift, five days a week, but today the site operates 12 hours a day, seven days a week and is headed towards being a full 24-hour/7-days a week site, according to the company. The current expansion also provides significant benefits to the local economy, including the addition of new high-tech jobs. The local staff has increased from 80 to 127 people, with a projected total of approximately 150 employees in the near future. At a ceremony commemorating the opening of the new wing, local dignitaries participated in the event, including Riverview Mayor Andrew Swift, Wayne County Executive Warren C. Evans, and other officials representing the City of Riverview, Wayne County, and Michigan Economic Development Corporation (MEDC).
Source: Piramal Pharma Solutions