Last year Catalent entered the gene therapy space, now the CDMO will expand into cell therapies through the acquisition of Masthercell from Orgenesis. The deal includes a plant in Belgium and a site under construction in Texas.

The deal sees contract development and manufacturing organization (CDMO) Catalent paying $315 million (€285 million) for Orgenesis’ third-party cell and gene therapy business Masthercell. Orgenesis will receive around $127 million of this with Masthercell’s backers Great Point Partners and SFPI-FPIM presumably receiving the rest.

For Catalent, the acquisition – expected to close in this current quarter – boosts its presence in the advanced therapy space. Masthercell has a cell therapy facility in Gosselies, Belgium, with 10 cleanrooms, four development labs, and in-house QC labs capable of manufacturing about 1,000 batches a year.

Image: iStock/designer491

Catalent will also gain a 30,000 square-foot cell therapy manufacturing plant in Houston, Texas, currently under construction and set to have a similar set-up to the Belgium site.

“More than 500 public and private companies have cell therapy programs underway, representing hundreds of active INDs, and more cell therapies are expected to gain approval in the coming years” Catalent spokesman Chris Halling told Bioprocess Insider.

“Masthercell is one of the very few development and manufacturing partners with the capacity, and the necessary technical expertise across multiple cell types at both clinical and commercial scale. With our expertise in scale-up, build-out and commercial-scale manufacturing we can help accelerate Masthercell’s growth and provide significant value to its current customers.”

Catalent’s M&A activity

Catalent has grown by following the demand for CDMO services from its early days as a softgel and small molecule technology supplier.

The firm opened its Madison, Wisconson biomanufacturing facility in 2013, and has steadily upped its presence across the biopharma space through expansions and acquisitions. In 2017, the CDMO acquired Cook Pharmica for $950 million, adding further biologics capabilities and fill/finish suites. The acquisitions of formulation development firm Juniper Pharma Services followed in 2018. And last year, the firm picked up an Italian fill/finish site from Bristol-Myers Squibb.

But 2019 also marked a move into advanced therapies, with Catalent making its largest acquisition to date with the $1.2 billion purchase of gene therapy CDMO Paragon Bioservices.

“Both autologous and allogeneic cell therapies provide important new treatment options, with a rising number expected to gain regulatory approval over the coming years,” Catalent CEO John Chiminski said.

“Masthercell extends our leadership position in the biotech industry, complements our leading gene therapy offering, and allows us to deliver comprehensive development, manufacturing, analytical, fill-finish, and clinical supply solutions for innovators across the large molecule space.”

Orgenesis

Orgenesis acquired Masthercell in 2015 for approximately $25 million in part to support the manufacturing of its cell therapies for diabetes.

According to Orgenesis CEO Vered Caplan, the sale will enable the further the development of her firm’s advanced therapy medicinal products and accelerate its point-of-care (POCare) cell therapy platform.

The firm is developing Autologous Insulin Producing (AIP) cells as a cell replacement therapy for the treatment of severe hypoglycemia-prone diabetes resulting from total pancreatectomy due to chronic pancreatitis.

Meanwhile, the localized POCare platform aims to collect, process and supply cells within the patient care setting for various therapeutic treatments. Orgenesis teamed with HYGEIA’s hospital network in December to develop and deliver onsite cell and gene therapies to patients.