Dalton Pharma Services has announced expanded cGMP sterile powder filling capabilities as part of its ongoing focus on sterile processing and manufacturing.
The expansion includes the addition of a high-speed automated sterile powder filling line that will enable Dalton to efficiently fill large commercial batches of vials. The new cGMP equipment will be installed in a dedicated suite with local Class A environment and isolator style containment.
Dalton will also be adding intermediate scale cGMP sterile powder filling equipment optimized to produce small to medium sized clinical trial batches. The new mid-scale equipment will be operated under a Class A environment and containment system. The new sterile manufacturing capacity is semi-automated and provides 100% check weighing for batches up to 10,000 vials.
These new capabilities combined with recent aseptic liquid filling enhancements at Dalton’s Toronto location, complement the company’s long standing experience with clinical scale filling of sterile powder filling into vials. This expansion will allow Dalton to compliantly meet its customer’s sterile powder filling requirements on any scale, and expand its capacity in specialized sterile manufacturing processes to larger scale projects.
As a Canadian company, Dalton provides the added advantage of reciprocity with the EU and Australian markets under the Mutual Recognition Agreement (MRA), providing simplified access to these markets for international customers.
The expansion is supported by $2.085 Million (Canadian Dollars) in FedDev Ontario funding through the Investing in Business Growth and Productivity Initiative. FedDev Ontario (Federal Economic Development Agency for Southern Ontario) is focused on helping established businesses to expand their operations, invest in productivity improvements and compete globally. The funding was announced at Dalton’s Toronto facilities on January 16, 2015 by Minister of State for FedDev Ontario, Gary Goodyear and Member of Parliament for York Centre, Mark Adler.
“The strategic decision to invest in specialized sterile powder filling was driven primarily by the demand in this market globally and by our existing customers”, said Peter Pekos, CEO & President, Dalton Pharma Services. “The significant investments we are making in these sterile manufacturing and development capabilities allow Dalton to maintain its leadership position in sterile powder manufacturing, and accelerate the application of these innovations to the leading-edge commercial pharmaceutical products of our customers.”