LSNE tapped for drug substance manufacturing, fill/finish services
The contract development and manufacturing organization (CDMO) has facilities in Bedford and Manchester, NH and specializes in various services, including cGMP fill/finish and lyophilization.
As part of its agreement with Selecta, LSNE will be providing drug substance manufacturing and fill/finish services.
The services will help Selecta advance its lead program, SEL-212, through the clinic to commercialization.
"We are happy to have LSNE's support as a clinical and commercial manufacturer of SVP-Rapamycin for SEL-212 and future product candidates,” Lloyd Johnston, Ph.D., Chief Operating Officer of Selecta commented in the press release.
The therapeutic enzyme is designed to be the first biologic treatment for gout, according to the company. A Phase II clinical trial was initiated at the end of October 2016.
FDA inspections
Lyophilization Services of New England, Inc. (LSNE) completed two FDA inspections of its aseptic manufacturing facilities in March of this year.
According to the company, the first inspection was an FDA Pre-Approval Inspection (PAI) of its aseptic manufacturing facility in Bedford, NH.
Following the inspection – which also served as a general GMP inspection – the facility was recommended for approval to manufacture the commercial sterile drug product for US distribution.
The second inspection was a general GMP inspection of LSNE's Harvey Road aseptic manufacturing facility.
Also in March, the company announced its acquisition by the private equity firm, Permira.
LSNE did not respond to a request for comment.
