Commercial development of cell-based therapeutics: strategic considerations along the drug to tissue spectrum.
In cell-based therapy, the process defines the product and the biological interaction between implant and host determines the outcome. Developing the optimum combination of process, product and a clinically relevant effect has been a challenge, leaving many potential therapies stalled in early clinical studies. This special report discusses pivotal factors in the development of cell-based technologies, irrespective of where they fit on the spectrum from cell-based drug to tissue construct, and how we can ensure delivery of an effective product to the clinic and the marketplace. Epidermal cell-based therapies serve as an historical lesson.
Parenteau
Nancy L
NL
Parenteau BioConsultants, LLC, PO Box 448, Fair Haven, VT 05743, USA. nlp@parenteaubc.com
D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D003132:Commerce; D000078404:Epidermal Cells; D044968:Regenerative Medicine / Q000379:methods* / Q000639:trends; D012449:Safety; D013234:Stem Cells / Q000166:cytology*; D023822:Tissue Engineering / Q000379:methods* / Q000639:trends