Enhancing Tissue Engineering and Regenerative Medicine Product Commercialization: The Role of Science in Regulatory Decision-Making for the TE/RM Product Development

2015 ◽  
Vol 21 (19-20) ◽  
pp. 2476-2479 ◽  
Author(s):  
Timothy A. Bertram ◽  
Peter C. Johnson ◽  
Bill J. Tawil ◽  
Mark Van Dyke ◽  
Kiki B. Hellman
Keyword(s):  
Decision Making ◽  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Product Development ◽  
Regulatory Decision ◽  
Medicine Product

Considerations for Tissue-Engineered and Regenerative Medicine Product Development Prior to Clinical Trials in the United States

2010 ◽  
Vol 16 (1) ◽  
pp. 41-54 ◽  
Author(s):  
Mark H. Lee ◽  
Judith A. Arcidiacono ◽  
Anastacia M. Bilek ◽  
Jeremiah J. Wille ◽  
Caitilin A. Hamill ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Regenerative Medicine ◽  
Product Development ◽  
The United States ◽  
Medicine Product

scholarly journals Decision Support Tools for Regenerative Medicine: Systematic Review (Preprint)

2018 ◽  
Author(s):  
Ching Lam ◽  
Edward Meinert ◽  
Abrar Alturkistani ◽  
Alison R. Carter ◽  
Jeffrey Karp ◽  
...  
Keyword(s):  
Tissue Engineering ◽  
Gene Therapy ◽  
Decision Support ◽  
Regenerative Medicine ◽  
Product Development ◽  
Cost Effective ◽  
Decision Support Tools ◽  
Cell Therapies ◽  
Allogeneic Cell Therapy ◽  
Support Tools

BACKGROUND Decisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain. Recent approved therapies in regenerative medicine have shown great clinical benefits to patients. OBJECTIVE The objective of this review was to investigate what decisional tools are available and what issues and gaps have been raised for their use in regenerative medicine. METHODS We systematically searched MEDLINE to identify articles on decision support tools relevant to tissue engineering, and cell and gene therapy, with the aim of identifying gaps for future decisional tool development. We included published studies in English including a description of decisional tools in regenerative medicines. We extracted data using a predesigned Excel table and assessed the data both quantitatively and qualitatively. RESULTS We identified 9 articles addressing key decisions in manufacturing and product development challenges in cell therapies. The decision objectives, parameters, assumptions, and solution methods were analyzed in detail. We found that all decisional tools focused on cell therapies, and 6 of the 9 reviews focused on allogeneic cell therapy products. We identified no available tools on tissue-engineering and gene therapy products. These studies addressed key decisions in manufacturing and product development challenges in cell therapies, such as choice of technology, through modeling. CONCLUSIONS Our review identified a limited number of decisional tools. While the monoclonal antibodies and biologics decisional tool domain has been well developed and has shown great importance in driving more cost-effective manufacturing processes and better investment decisions, there is a lot to be learned in the regenerative medicine domain. There is ample space for expansion, especially with regard to autologous cell therapies, tissue engineering, and gene therapies. To consider the problem more comprehensively, the full needle-to-needle process should be modeled and evaluated.

scholarly journals Liposomes in tissue engineering and regenerative medicine

2014 ◽  
Vol 11 (101) ◽  
pp. 20140459 ◽  
Author(s):  
Nelson Monteiro ◽  
Albino Martins ◽  
Rui L. Reis ◽  
Nuno M. Neves
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Potential Role ◽  
Lipid Membrane ◽  
Cultured Cells ◽  
Cell Types ◽  
Biomaterial Scaffolds ◽  
Bioactive Agents ◽  
The 1960S

Liposomes are vesicular structures made of lipids that are formed in aqueous solutions. Structurally, they resemble the lipid membrane of living cells. Therefore, they have been widely investigated, since the 1960s, as models to study the cell membrane, and as carriers for protection and/or delivery of bioactive agents. They have been used in different areas of research including vaccines, imaging, applications in cosmetics and tissue engineering. Tissue engineering is defined as a strategy for promoting the regeneration of tissues for the human body. This strategy may involve the coordinated application of defined cell types with structured biomaterial scaffolds to produce living structures. To create a new tissue, based on this strategy, a controlled stimulation of cultured cells is needed, through a systematic combination of bioactive agents and mechanical signals. In this review, we highlight the potential role of liposomes as a platform for the sustained and local delivery of bioactive agents for tissue engineering and regenerative medicine approaches.

Role of Cells in Freezing-Induced Cell-Fluid Matrix Interactions Within Engineered Tissues

2012 ◽  
Author(s):  
Angela Seawright ◽  
Altug Ozcelikkale ◽  
J. Craig Dutton ◽  
Bumsoo Han
Keyword(s):  
Tissue Engineering ◽  
Extracellular Matrix ◽  
Regenerative Medicine ◽  
Biological Tissues ◽  
Cellular Viability ◽  
Long Term Storage ◽  
Matrix Interactions ◽  
Term Storage

Cryopreservation can provide long-term storage of various biological tissues, which has significant impact on tissue engineering and regenerative medicine. For successful cryopreservation of tissues, tissue functionality must be maintained including physical properties such as mechanical, optical, and transport properties, as well as cellular viability. Such properties are associated with the extracellular matrix (ECM) microstructure. Thus, the preservation of the ECM microstructure may lead to successful cryopreservation [1,2]. Yet, there is still very little known about changes in the ECM microstructure during freezing/thawing.

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