Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.
|Articles|February 15, 2020
- BioPharm International-02-15-2020
- Volume 2020 eBook
- Issue 1
Using the “Cubic Effect” to Drive Cell and Gene Therapy Commercialization
Author(s)Alberto Santagostino
Contract partners must help innovator biotechs consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.
Advertisement
The cell and gene therapy industry is at a major inflection point, as therapies move out of clinical trials and into the commercial market. As more therapies are commercialized and become established, demand for cell and gene therapies will grow, leading to vast changes in patient care.
Article Details
BioPharm International
eBook: Outsourcing Resources, February 2020
February 2020
Pages: 12–15
Citation
When referring to this article, please cite it as A. Santagostino, “Using the “Cubic Effect” to Drive Cell and Gene Therapy Commercialization," BioPharm International Outsourcing Resources eBook (February 2020).
Articles in this issue
over 6 years ago
Biopharma Contract Market Updateover 6 years ago
Building Strategic Relationships with CROsover 6 years ago
Digitalization: A CDMO’s Perspectiveover 6 years ago
More Capacity and Technology Translate to More Optionsover 6 years ago
Sourcing Success in Cell and Gene Therapy Developmentover 6 years ago
Growth in Biologics Market Inspires OutsourcingAdvertisement
Related to this article
Four cell therapy developers have pulled back from ex vivo manufacturing in the past month — ArsenalBio, TScan Therapeutics, and Cellectis all pivoted to in vivo approaches, while Bristol Myers Squibb terminated its manufacturing partnership with automation specialist Cellares after determining its platform couldn't meet requirements for commercial Breyanzi production, triggering layoffs.
mAbxience and Sandoz are targeting a $5.7 billion market with a proposed emicizumab biosimilar for hemophilia A.
Samsung Biologics signed a $262 million contract manufacturing agreement with an undisclosed European pharmaceutical company, extending production commitments through 2033 and lifting the CDMO's cumulative contract value past $21.9 billion.
Encoded Therapeutics closed a $275 million Series F financing to fund pivotal and expansion studies of ETX101, an AAV9-mediated gene regulation therapy for SCN1A-positive Dravet syndrome, alongside commercial-scale buildout of the company's in-house GMP manufacturing.
Advertisement
Advertisement