In June 2016, the autologous cell and gene therapy company announced it was winding down its Laviv axficel-T operations after missing the primary endpoints a Phase II clinical trial the treatment of vocal cord scarring resulting in chronic or severe dysphonia.
The US FDA had approved Laviv in 2011 as a personalised cell therapy for use in aesthetics – used to treat ‘smile line’ wrinkles – and the product was made commercially at Fibrocell’s 13,000 square foot Exton, Pennsylvania facility.
But now the site will be used to make clinical (and potentially commercial) batches of FCX-007, an autologous gene therapy Fibrocell is developing to treat orphan skin disease RDEB, the firm said during a recent Q3 financial call.
“Our existing cGMP cell therapy manufacturing facility in Exton, Pennsylvania, has been designated as the production site for FCX-007 after incorporation into the IND,” said CEO John Maslowski.
“The facility will be used for the remaining clinical and future commercial manufacture of FCX-007, with capacity to serve the US market for RDEB.”
He added having an in-house manufacturing solution for gene therapies provides an advantage for companies by “allowing full-control of scheduling priority, inventory and compliance, while operating in a more cost-effective fashion.”
The plant is already equipped with cleanroom cell therapy manufacturing, quality control testing, cryogenic storage, shipping and receiving, and warehousing space, and having already run it for commercial operations, the plant is “a valuable asset to Fibrocell, mitigating the need for a large capital investment in future,” according to Maslowski.
“Because the facility was previously used for an approved commercial product, all those systems that we created and were reviewed as part of the pre-license inspection in the several routine team biologics inspection we had, [have left the plant complete with] systems for commercial readiness.”
And, he continued, as the FCX-007 process is based on the former azficel-T process Fibrocell is unlikely to need make significant purchases for basic equipment.
“Of course, we'll have things like ramping up with additional operators and staff, and bringing in more raw materials and things like that. But the basic structure is here, already in place just based on our previous experience.”