Investment intended to meet demand for critical finishing services.
With the accelerating development of biopharmaceuticals as well as the prevalence and predominance of other parenterally delivered medicines, the need for sterile fill/finish services will continue to be in high demand. This critical need is also exacerbated because the majority of quality excursions associated with injectable drugs are introduced at the fill/finish stage and identified as a cause of drug shortages.
In pursuit of this business, contract manufacturer Patheon announced it recently completed an expansion of its sterile fill/finish operations, adding 7,000 sq. ft. of new capacity at its Greenville, North Carolina facility. According to Patheon, its $26 million investment updates its Sterile Development Services (PDS) suites with “state-of-the-art” integration and isolation desired by regulators and essential to meeting cGMP-standards; a best practice and virtually mandatory for any pharma capacity being introduced today.
“As the industry continues to innovate, customers will require even more advanced solutions, integrating development and commercial service, to meet their business needs,” said Franco Negron, President of Patheon’s Drug Product and Pharmaceutical Development Services.
Patheon said the expansion covers two new lines which will be employed to manufacture liquid and lyophilized parental drugs. Incorporating freeze-drying integrated filling within restricted access barrier systems (RABs) and disposables, the company said it will realize a number of operational benefits including shortened set-up times, more positive cleaning verification, less product loss and most importantly, sterility assurance.
Home to the company’s recent foray into continuous manufacturing capability, Patheon’s Greenville site offers a wide range of contract services covering everything from oral solid dose small molecule drugs to the lyophilization of large-molecule biopharmaceuticals and the subsequent fill/finish and packaging of client products.