Large scale expansion of API manufacturing facilities on the cards
As part of its efforts to expand API manufacturing capabilities and capacities, Piramal Pharma Solutions (PPS) — a leading Contract Development and Manufacturing Organisation (CDMO) and part of $1.3-billion Piramal Enterprises Ltd (PEL) — has announced investments of $55 million across its sites in North America and Asia.
“We are committed towards investing in our customers future needs. With these investments, we can now support the commercialisation of our pipeline of over 80 programmes that are at Phase II or beyond, while allowing us additional capacity for future partnerships,” said Vivek Sharma, CEO, Piramal Pharma Solutions.
“There has been significant customer interest in our ‘integrated’ offerings, and we are pleased to have over 60 integrated programs at PPS across all phases of drug development. We thank our customers for their trust and support and promise to continue the focus on the three pillars that made us their Partner of Choice: Customer Centricity, Quality, and Innovation,” he added.
A part of this investment will go into new state-of-the-art, multi-purpose plants, with over 270kL of total capacity, to support the current pipeline of approximately 80 late stage programs that PPS is currently assisting its partners with at various global sites, the company said in a statement.
PPS will also expand its potency footprint (new Occupational Exposure Limit: ≥10 ng/m3) at its plant in Riverview, Michigan, while augmenting early development capabilities out of Ennore, India through additions of GMP kilo labs and a pilot plant.
To serve its European biotech customers better, PPS will add early development capabilities in both, drug substance and drug product, out of its Morpeth, UK facility. Support functions such as analytical capabilities, R&D infrastructure, automation, and IT systems will also be expanded at all API sites through this investment.
Piramal supports API development and manufacturing through an integrated model across its five sites in North America, Europe and Asia. API Development activities including route scouting and process development are conducted at facilities in Aurora (CA), Ennore (India) and Riverview (USA). These facilities are forward integrated with commercial API manufacturing units at Aurora (CA), Ennore (India), Digwal (India), Morpeth (UK) and Riverview (USA).