Stephen Squinto, PhD, Passage Bio’s co-founder and interim CEO

Passage Bio, a developer of gene therapies for rare monogenic CNS diseases launched five months ago, will partner with Catalent’s Paragon Gene Therapy unit to develop a dedicated manufacturing suite at Paragon’s Harmans, MD, facility.

The cGMP suite, whose value was not disclosed, is expected to begin operation in the second half of 2020, and support Passage Bio’s supply needs from clinical through commercial phases.

The suite is within the 151,000-square-foot former warehouse that Paragon converted into a contract developing and manufacturing facility that opened in April.

“Passage will work contractually with Paragon to conduct GMP manufacturing batches of our AAV material for clinical development across all three programs that are on track for clinical development in 2020. Beyond that we expect to be utilizing our new dedicated suite for all future GMP manufacturing needs,” Stephen Squinto, PhD, co-founder and interim CEO at Passage Bio, told GEN on Wednesday.

Passage Bio is in IND-enabling phases for three of its programs, of which two are expected to begin clinical development in the first half of 2020—programs to treat GM1 gangliosidosis by targeting the lysosomal enzyme β-galactosidase (GLB1) and frontotemporal dementia by targeting the gene encoding the lysosomal protein progranulin (PGRN).

A third program (GTP-206) aimed at treating Krabbe disease by targeting the gene encoding the hydrolytic enzyme galactosylceramidase (GALC) was announced May 30, and is set to enter the clinic in the second half of 2020.

The manufacturing suite will be approximately five miles southwest of Baltimore/Washington International Thurgood Marshall Airport, and 112 miles southwest of Passage Bio’s corporate headquarters in Philadelphia.

In a statement announcing the collaboration, Squinto added that Passage Bio securing its own dedicated manufacturing suite by partnering with Paragon “is a key facet of our business plan.”

Added Pete Buzy, president of Paragon Gene Therapy, in the statement: “Combining Passage Bio’s scientific knowledge with our world-class facilities and extensive AAV scale-up expertise perfectly aligns with our strategic goals in this time of gene therapy growth.”

Using Pall’s iCELLis bioreactor

iCELLis® single-use fixed-bed bioreactor [Pall]
Passage Bio said its new suite will use Pall’s iCELLis® single-use fixed-bed bioreactor technology, a fully-integrated fixed-bed bioreactor system designed to provide a scalable alternative for the cultivation of adherent cells, allow for a more robust and reproducible process, and thus meet demand for both clinical and commercial-scale volumes. According to Pall, iCELLis is an automated, single-use 500+ bioreactor with disposable, pre-installed calibrated probes.

Paragon is a contract development and manufacturing organization (CDMO) focused on gene therapies. The company is based at University of Maryland (UM) BioPark in Baltimore, on the academic medical center campus of the University of Maryland, Baltimore (UMB).

Paragon was known as Paragon Bioservices when it was acquired by Catalent for $1.2 billion in a deal completed May 20. Through the acquisition, Catalent expanded its capabilities into the gene therapy field with a leading developer and manufacturer of viral vectors.

“Together with Paragon, we will be uniquely positioned to enable the research, development, and production of gene therapies and other complex biologics for the success of our customers and the benefit of their patients,” Catalent chair and CEO John Chiminski said in a video announcing the deal.

Passage Bio was launched in February with $115.5 million in Series A financing to develop a portfolio of five therapeutic candidates that incorporate adeno-associated virus (AAV) technologies developed by pioneer gene therapy researcher James M. Wilson, MD, PhD, a co-founder of the company, and colleagues at the University of Pennsylvania (Penn) and its Gene Therapy Program (GTP).

“Penn has had a long-standing relationship with Paragon, and Paragon is one of the few vendors familiar with the iCELLis manufacturing system that Passage Bio will employ,” Squinto told GEN.

That relationship is one of two factors that attracted Passage Bio to Paragon’s facility, Squinto added: “Second, we are quite impressed with the deep skill set of the Paragon team across viral manufacturing, regulatory, and quality functions.”

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