BrainStorm’s cell therapy: Catalent high on NurOwn supply

BrainStorm Cell Therapeutics is eying the potential launch of NurOwn and has selected CDMO Catalent to produce the autologous cell therapy from its site in Texas.

Known as NurOwn, MSC-NTF is cell therapy candidate being investigated in Phase III trials for Amyotrophic Lateral Sclerosis (ALS) by BrainStorm. The potential therapy is made from bone marrow-derived mesenchymal stem cells (MSCs) taken from the patient, which are expanded and differentiated ex vivo before being converted into MSC-NTF cells that secrete high levels of neurotrophic factors (NTFs) and administered back into the patient.

As the firm looks to commercialization, it is set to carry out a tech transfer to a facility in Houston, Texas run by contract development and manufacturing organization (CDMO) Catalent.

Image: Stock Photo Secrets

“The successful completion of this technology transfer with Catalent is an important step in establishing manufacturing preparedness for NurOwn,” said Chaim Lebovits, CEO of Brainstorm. “The manufacturing of cellular therapies such as NurOwn is complex and requires careful planning and very specific expertise. We are very pleased with the progress we have made with our partner Catalent, which has industry-leading capabilities in this area.”

Catalent’s stock price rose 4% following the announcement of the tech transfer.

CGT business

The 32,000 square-foot Houston facility was added to Catalent’s network in February 2020 – alongside a facility in Gosselies – Belgium, through the $315 million acquisition of Orgenesis’ third-party cell and gene therapy business Masthercell.

“The facility opened in Q1 2020, and clinical manufacturing on behalf of a customer commenced in April 2021,” Colleen Floreck, VP of Global Marketing and Strategy at Catalent Cell and Gene Therapy told BioProcess Insider.

Since then, much of the capacity at the Houston facility has been allocated to customer programs, we were told, though specific utilization rates were not divulged.

However, Floreck said “Catalent will continue to grow and invest in the cell therapy market, not only to accommodate existing customers as their programs expand, but for new projects… This is a fast-growing market, with many new approvals expected this year, and more to come.”

Catalent entered the advanced therapy space in 2019 through the $1.2 billion purchase of gene therapy CDMO Paragon Bioservices. The CDMO has expanded rapidly since them, with the purchase of RheinCell Therapeutics in Dusseldorf and its GMP iPSC cell lines in August 2021 complementing the Masthercell buy. Meanwhile, a $230 million expansion project at the firm’s gene therapy campus in Harmans, Maryland began last month.