Cell therapy bioprocessing has advanced from limited efforts in specialized laboratories and academic institutions to becoming part of the mainstream biologics industry, with hundreds of companies involved and 20 product approvals in the United States (and more elsewhere). This featured report takes a snapshot of the processing issues of today — manufacturing platforms, purification of viral vectors for gene therapy, three-dimensional bioprinting — and looks toward the future of this biologics market segment.
Introduction: Process Issues in Cell, Gene, and Tissue Therapies
BPI’s managing editor reviews current process issues for cell, gene, and tissue therapies — focusing in particular on cell expansion, product purification, and engineering approaches. She also introduces the authors and topics presented in this featured report.
Growth Projections for the Regenerative Medicine Market
After many trials, errors, and milestones, regenerative medicine has become a mainstream part of the biologics industry, supported by at least 670 companies and clinics of all sizes and 20 products approved by the US Food and Drug Administration so far. As this author from Allied Market Research shows, markets for all segments of regenerative medicine are growing quickly and projected to extend well into the next decade.
Platform Solutions for Cell Therapy Manufacturing
Cell therapy manufacturers have a choice between traditional 2D cell-expansion systems (e.g., stacked trays and flasks) and 3D suspension bioreactors of various designs that typically require 2D surfaces such as microcarriers for adherent (anchorage-dependent) cells. As these authors from Lonza point out, one platform does not fit all products in development. Manufacturers must take several factors into consideration when choosing a technology, including how that choice will affect the efficiency of recovery and harvest.
Expansion Platform Components
BPI’s managing editor interviews Corning’s Chris Mach on the challenges that biomanufacturers face regarding cell expansion, with a focus on stack vessels, chemical defined media, and microcarriers.
Scalable Purification of Viral Vectors for Gene Therapy:
An Appraisal of Downstream Processing Approaches
Process concerns associated with viral-vectors gene delivery currently focus on effective purification, as described by these authors from the Centre for the Advancement of Sustainable Medical Innovation and Sartorius Stedim Biotech. For research into cell-delivered gene therapy platforms to continue toward development, process characterization and development work are still in need of refinement.
3D Bioprinting Possibilities and Challenges
Tissue therapies such as allografts and xenografts for burn and wound healing have seen steady success in regenerative medicine. Implementation of stem cells and cultured epithelial cells presents exciting opportunities in improving both patient comfort and therapeutic delivery. As the managing editor describes here, novel application systems are in the works.