In the last decade, cell therapies, gene therapies, and regenerative medicines, broadly and sometimes interchangeably defined as Advanced Therapy Medicinal Products (ATMPs), have gained significant importance as therapeutic modalities for a host of human disorders. By 2025, this market is projected to grow to over €130 billion (US$144 billion).1
In 2019, there were over 1,071 cell and gene therapy related clinical trials ongoing globally, and $7.5 billion of capital deployed in this sector in the first nine months of the year. 2
But manufacturing and delivery of ATMPs is substantially more complex than for typical drug products. Most biotechnology companies and research institutes lack the infrastructure or expertise to scale their manufacturing operations.
Due to the complexity and diversity of the ATMPs in development, solutions are often customized to the particular needs of each specific therapy, and, accordingly, a multidisciplinary team of engineers, cell therapy experts, GMP (Good Manufacturing Practices) and regulatory experts is required. This complexity casts a spotlight on improved GMP and scaled-up manufacturing processes.
Orgenesis has built a platform of know-how and expertise for developing and manufacturing ATMPs. We have deep technical experience in all facets of this industry, including immuno-oncology, ex-vivo gene therapies, regenerative medicines, and in-vivo gene editing, among others.
Through our Cell & Gene Therapy Biotech Platform, Orgenesis is developing a pipeline of internal and in-licensed therapies for which the company retains development and marketing rights as they progress through the clinic.
We have operations in the United States, Europe, Israel and South Korea, and our international network of POCare facilities will serve a multitude patients in the coming years, directly in the hospital setting.
As the availability and demand for ATMPs grows globally, Orgenesis is positioned to capture and shape this rapidly expanding and evolving cell and gene therapy ecosystem.
- Roland Berger Focus: Regenerative Medicine. October, 2017.
- Alliance for Regenerative Medicine presentation: Gene Therapies – A Global Sector Overview. October, 2019