New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)
Piramal Pharma Solutions has begun production of initial batches of active pharmaceutical ingredients (APIs) in new reactor suites at its facility in Riverview, Michigan, USA.
Construction of the capacity expansion at Riverview, known as Project PRIME (Piramal Riverview Integrated Manufacturing Expansion) Phase 1, was kicked off in May of 2021. The initial production run is the culmination of a capital expenditure of $38 million in equipment and construction costs.
The facility covers approximately 25,000 square feet of space and includes production, warehousing and supporting utilities. It is readily scalable to accommodate additional reactor bays, which are planned as part of Project PRIME Phase 2.
The featured technology in the new facility is 10 kl of reactor capacity accompanied by a pressure dryer filter. The reactors are capable of producing high potency APIs with low Occupational Exposure Levels (OELs) of >1μg/m3.
It brings additional capacity to our North American offering, which we believe satisfies the market’s current high demand for APIs
The initial production batches represent the first step in a three-step process for the development and manufacturing of Phase II clinical trial materials. As part of the program, Piramal technicians are scaling up material from 10-15 kg to 75-80 kg.
According to Peter DeYoung, Chief Executive Officer, Piramal Global Pharma: “Getting Project PRIME Phase 1 online is an important milestone for Piramal Pharma Solutions and the Riverview site team. It brings additional capacity to our North American offering, which we believe satisfies the market’s current high demand for APIs. It also addresses the industry trend for onshoring of drug substance production. When coupled with the recent expansion of our API capabilities in Aurora, Canada, we believe that we are ready and able to support the market with both potent and non-potent APIs, from clinical to commercial scale.”
The recently completed expansion at Piramal’s API site in Aurora, Ontario, was part of a CAD $30 million capital investment. The new plant features more than ten thousand square feet of manufacturing and utility space and includes two new reactor suites with additional filtration and drying capabilities.