Sterile CMO round-up: news from Vetter, Dalton and LSNE

By Dan Stanton contact

- Last updated on GMT

Photo c/o Vetter
Photo c/o Vetter

Related tags: Pharmacology

An expansion at Vetter, a contract win for Dalton and a pre-approval inspection at LSNE – welcome to Outsourcing-Pharma’s round-up of sterile manufacturing news.

First up, Germany-headquartered contract development and manufacturing organization (CDMO) Vetter has completed an expansion of its aseptic filling facility in Skokie, Illinois which it says doubles the site’s capacities for performing visual inspection and In-Process Control (IPC).

Increased customer and predicted future demand drove the expansion at the facility just North of Chicago, which has also added an additional staff shift for daily clinical manufacturing operations and extra options for clients looking for secondary packaging services, thanks to a long-term collaboration with clinical packaging firm Sentry BioPharma Services.

“[The facility] has successfully passed audits and qualifications by as many as 30 companies, including 9 of the top 20 leading (bio-)pharmaceutical companies,”​ Vetter’s Managing Director Peter Soelkner said. “Our outlook for future performance is very positive as demonstrated by a pipeline filled with high quality customer projects for biologics.”

Dalton

Heading East and across a couple of Great Lakes next, we arrive at Toronto, Canada from where cGMP services firm Dalton Pharma Services will manufacture clinical supplies of a sterile large molecule for Andes Biotechnologies.

The cancer drug candidate was developed by Andes using its RNA silencing technology and Cristián Hernández-Cuevas, Andes’ CEO, said Dalton was “an excellent fit”​ as the Santiago, Chile-based company looks to enter Phase I clinical trials.

“They [Dalton] bring years of experience in manufacturing sterile injectable products and they have also invested significantly in optimizing their sterile facilities in the past year to meet current regulatory requirements.”

In January​ the CDMO increased the plant’s sterile powder filling capabilities as part of ongoing expansion plans focusing on sterile processing and manufacturing.

LSNE

Continuing East and crossing back into the US, Lyophilization Services of New England (LSNE) has announced its plant in Bedford, New Hampshire has successfully completed a US Food and Drug Administration (FDA) pre-approval inspection.

The Agency visited in April and has recommended the site for approval clearing the way for the manufacture of a commercial drug product for US distribution.

“The completion of this inspection is a critical milestone for LSNE,”​ the firm’s CEO Shawn Cain said. “This demonstrates LSNE’s commitment to meeting all applicable regulatory standards for the production of commercial medical devices, bulk intermediates and sterile injectable drugs.”

LSNE has three plants, offering lyophilisation services to the biopharma industry. According to the firm, it is looking to increase its manufacturing capacity, as well as expand its QC analytical testing capabilities, ICH stability chambers, and add complex formulation capabilities.

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