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Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.
Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization.
Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization. Contract development and manufacturing organizations (CDMOs) will play a key role in helping the cell-therapy industry to realize its potential, according to Mark Bamforth, president and CEO of Brammer Bio, which was formed in late March 2016 through the merger of Brammer Biopharmaceuticals and Florida Biologix as a CDMO focused on offering cell- and gene-therapy development and manufacturing services.
Not just any CDMO will do, however. “To tackle the challenges posed by these novel technologies and help accelerate their transition from the clinic to patients in need, CDMOs must have the necessary laboratory and production capabilities and a highly skilled team of scientists with specialized development, manufacturing, and analytical expertise, and a robust quality system to ensure compliance and product safety,” Bamforth says.
While there are a number of CMOs in the United States and Europe with experience in manufacturing retroviral, lentiviral, and adeno-associated virus vectors under GMPs, there are few GMP manufacturers with experience in the manufacture and release of cellular therapies, notes Bruce McCreedy, senior vice-president of cell therapy at Precision BioSciences. He adds that most of the larger companies involved in the development of CAR-T products have elected to build or acquire their own facilities and manufacture their products in-house. Brammer Bio and the few other CDMOs in this space (WuXi PharmaTech, which is building its third cGMP cell-therapy production facility in Philadelphia; PCT; and Lonza) are targeting smaller biotechs and large manufacturers that prefer to work with strategic contract partners.
Article DetailsBioPharm International
Vol. 29, No. 5
Citation: When referring to this article, please cite it as C. Challener, "Role of contract manufacturing in cell therapy development and manufacturing" sidebar to "Realizing the Potential of CAR-T Cell Therapies," BioPharm International 29 (5) 2016.