Piramal Pharma Solutions expands sterile manufacturing capacity in US

Invests $25 million to expand commercial aseptic manufacturing in Lexington, Kentucky

Piramal's facility in Lexington, Kentucky

Piramal Pharma Solutions, a provider of sterile drug product development and manufacturing services, is to expand its facilities in Lexington, Kentucky, US, in a $25 million expansion.

The firm plans to extend its capabilities and capacity for commercial aseptic manufacturing at the site.

This will be done by increasing vial filling capability and lyophilisation (spray drying) capacity, as well as upgrades to the associated facilities and utilities.

Piramal’s Lexington site has a strong pipeline of products, which are expected to be commercialised in the next 3–5 years.

The firm also noted that the fast-growing sterile market in the US, recent consolidations among contract manufacturing organisations in the region, plus the closure of many manufacturing sites in the US, has created demand for quality manufacturers in the segment.

The sterile market in the US and Europe is growing at 11%, while contract manufacturing in sterile dosage forms is increasing at 13% year-on-year.

Piramal said it expects to take advantage of these trends and grow its Lexington business 'multi-fold' times.

Bill Wedlake; 'We aim to become the leading aseptic manufacturing service provider, a process that began with the acquisition of Coldstream Laboratories in January 2015'

Phase 1 of the expansion will add a new manufacturing suite kitted out with a high speed vial filling machine that a provides controlled, safe environment for handling potent materials. It also has the advantage of automated vial washing and sterilisation.

Also as part of the first phase of expansion, Piramal will install a new isolator-based vial filler in the existing manufacturing suite, which is a newer technology and reaches much higher quality standards.

When combined, these two fillers will increase the company’s vial filling capabilities by more than five times.

Phase 2 of the expansion will include the installation of two lyophilisers, which are planned to integrate with the new filler line in the new manufacturing suite. They will provide dedicated capacity for both potent and non-potent products.

Vivek Sharma, CEO, Pharma Solutions, Piramal Enterprises, said: 'Since our initial investment the Kentucky site has demonstrated both leadership and growth, and we are pleased to announce this next phase of investment to enhance capability and capacity.

'The expansion in our capacity at Kentucky will help us better serve our customers who are looking for us to deliver solutions that will improve the standard of care.'

Bill Wedlake, President of Piramal Pharma Solutions Formulations Business, added: 'We are extremely excited to initiate this expansion and continue the company’s vision of becoming the premier aseptic manufacturing service provider that began with the acquisition of Coldstream Laboratories in January of 2015.'