Rights of Passage: Paragon building dedicated gene therapy suite

CDMO Catalent’s unit Paragon will construct a dedicated manufacturing suite in Maryland to service Passage Bio’s clinical and commercial gene therapies using fixed-bed bioreactor technology.

Paragon Bioservices – renamed Paragon Gene Therapy following its $1.2 billion (€1.1 billion) acquisition by contract development and manufacturing organization (CDMO) – has been selected by Philadelphia-based Passage Bio to manufacture its AAV-delivered gene therapies for monogenic central nervous system diseases.

As such, the CDMO will build a dedicated suite in Harmans, Maryland, near Baltimore Washington Airport, set to be operational in late 2020, capable of supporting both clinical and commercial manufacturing.

Passage did not respond to Bioprocess Insider’s request for more information but Stephen Squinto, co-founder and interim chief executive officer, said securing its own dedicated manufacturing suite “is a key facet” in supporting the critical manufacturing element of its gene therapy programs.

The firm’s lead gene therapies targeting GM1 gangliosidosis, frontotemporal dementia (FTD) and Krabbe disease are set to enter the clinic next year.

From a manufacturing stance, the firm has selected Pall’s iCELLis single-use fixed-bed bioreactor, which it says is a scalable alternative for the cultivation of adherent cells.

Dedicated and expanding

Paragon has a 200,000 square-foot GMP gene therapy biomanufacturing facility in Anne Arundel County, Maryland.

However, the high demand for vector production and gene therapy services has meant some commentators have suggested the CDMO is susceptible to maxing out its capacity.

As such, Paragon inked a deal earlier this month to increase its production footprint by 65% by taking over the lease of two facilities in Rockville and Gaithersburg, Maryland from vaccine maker Novavax.

However, Paragon has also been supporting clients through the construction of dedicated facilities, with Passage being the latest example.

The firm inked a deal with long-term client Sarepta last October to provide additional commercial manufacturing capacity for Sarepta’s micro-dystrophin Duchenne muscular dystrophy (DMD) gene therapy candidate. In April this year, Paragon announced it is establishing a second dedicated suite to support Sarepta further.