Promising Growth and Investment in the Cell Therapy Industry during the First Quarter of 2012

Brindley, David; Davie, Natasha L.; Sahlman, William A.; Bonfiglio, Gregory A.; Culme-Seymour, Emily; Reeve, Brock; Mason, Chris

doi:10.1016/j.stem.2012.04.018

Cited by 13 publications

(9 citation statements)

References 9 publications

(8 reference statements)

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“…multilineage differentiation features), or bioprocess development‐related issues, such as the definition of culture parameters for stem cell expansion and controlled differentiation, the cell‐based therapies industry has nonetheless been showing sustainable growth. In fact, US publicly traded cell‐based therapy companies captured approximately $85 million in new capital in the first quarter of 2012 [1], which could be seen as a sign of community recognition of the potential of these therapies. As an emerging field that mainly originated within small start‐up companies lacking the technological and product development pipelines of big pharmaceutical companies, stem cell‐based cell therapies are expensive and may be arduous to implement and commercialize.…”

Section: The Stem Cell‐based Therapies Fieldmentioning

confidence: 99%

Bioreactor design for clinical‐grade expansion of stem cells

Santos

Andrade

Silva

et al. 2013

Biotechnology Journal

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The many clinical trials currently in progress will likely lead to the widespread use of stem cell-based therapies for an extensive variety of diseases, either in autologous or allogeneic settings. With the current pace of progress, in a few years' time, the field of stem cell-based therapy should be able to respond to the market demand for safe, robust and clinically efficient stem cell-based therapeutics. Due to the limited number of stem cells that can be obtained from a single donor, one of the major challenges on the roadmap for regulatory approval of such medicinal products is the expansion of stem cells using Good Manufacturing Practices (GMP)-compliant culture systems. In fact, manufacturing costs, which include production and quality control procedures, may be the main hurdle for developing cost-effective stem cell therapies. Bioreactors provide a viable alternative to the traditional static culture systems in that bioreactors provide the required scalability, incorporate monitoring and control tools, and possess the operational flexibility to be adapted to the differing requirements imposed by various clinical applications. Bioreactor systems face a number of issues when incorporated into stem cell expansion protocols, both during development at the research level and when bioreactors are used in on-going clinical trials. This review provides an overview of the issues that must be confronted during the development of GMP-compliant bioreactors systems used to support the various clinical applications employing stem cells.

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Section: The Stem Cell‐based Therapies Fieldmentioning

confidence: 99%

Bioreactor design for clinical‐grade expansion of stem cells

Santos

Andrade

Silva

et al. 2013

Biotechnology Journal

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“…The translation of promising lab-scale cell based regenerative medicine and tissue engineering (TE) therapies to large-scale commercial production is hampered by a lack of robust and cost-effective manufacturing processes that can deliver effective, regulatory-compliant, and safe cellular products (Brindley et al, 2012;Mason and Manzotti, 2010). Bioreactors for 3-dimensional (3D) TE have demonstrated their potential as a cost-effective and highly automated production platform showing great promise for both the up and scale-out strategies (Dos Santos et al, 2013;Martin et al, 2009).…”

Section: Introductionmentioning

confidence: 99%

Model‐based cell number quantification using online single‐oxygen sensor data for tissue engineering perfusion bioreactors

Lambrechts

Papantoniou

Sonnaert

et al. 2014

Biotech & Bioengineering

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Online and non-invasive quantification of critical tissue engineering (TE) construct quality attributes in TE bioreactors is indispensable for the cost-effective up-scaling and automation of cellular construct manufacturing. However, appropriate monitoring techniques for cellular constructs in bioreactors are still lacking. This study presents a generic and robust approach to determine cell number and metabolic activity of cell-based TE constructs in perfusion bioreactors based on single oxygen sensor data in dynamic perfusion conditions. A data-based mechanistic modeling technique was used that is able to correlate the number of cells within the scaffold (R(2) = 0.80) and the metabolic activity of the cells (R(2) = 0.82) to the dynamics of the oxygen response to step changes in the perfusion rate. This generic non-destructive measurement technique is effective for a large range of cells, from as low as 1.0 × 10(5) cells to potentially multiple millions of cells, and can open-up new possibilities for effective bioprocess monitoring.

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“…Cell therapy is an exponentially growing field with >2,500 clinical trials in the world over the last 10 years [1] . Cell-based therapeutic products are positioned as a billion dollar per year industry with anticipated market growth [2] , [3] . The method of using cells as drugs is particularly advantageous when a higher-order approach to treatment is required.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of Natural and Engineered Secreted Factors Delivered by Mesenchymal Stromal Cells

et al. 2014

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Transient cell therapy is an emerging drug class that requires new approaches for pharmacological monitoring during use. Human mesenchymal stem cells (MSCs) are a clinically-tested transient cell therapeutic that naturally secrete anti-inflammatory factors to attenuate immune-mediated diseases. MSCs were used as a proof-of-concept with the hypothesis that measuring the release of secreted factors after cell transplantation, rather than the biodistribution of the cells alone, would be an alternative monitoring tool to understand the exposure of a subject to MSCs. By comparing cellular engraftment and the associated serum concentration of secreted factors released from the graft, we observed clear differences between the pharmacokinetics of MSCs and their secreted factors. Exploration of the effects of natural or engineered secreted proteins, active cellular secretion pathways, and clearance mechanisms revealed novel aspects that affect the systemic exposure of the host to secreted factors from a cellular therapeutic. We assert that a combined consideration of cell delivery strategies and molecular pharmacokinetics can provide a more predictive model for outcomes of MSC transplantation and potentially other transient cell therapeutics.

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Promising Growth and Investment in the Cell Therapy Industry during the First Quarter of 2012

Abstract: In the first quarter of 2012, publicly traded companies in the cell-based therapy industry continued to show promising overall growth. Highlights included $85 million in new capital investment and steady clinical trial progress.

Cited by 13 publications

References 9 publications

Bioreactor design for clinical‐grade expansion of stem cells

Bioreactor design for clinical‐grade expansion of stem cells

Model‐based cell number quantification using online single‐oxygen sensor data for tissue engineering perfusion bioreactors

Pharmacokinetics of Natural and Engineered Secreted Factors Delivered by Mesenchymal Stromal Cells

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