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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Issue Vol 2 Issue 1

Non-viral vectors for gene therapy

Editorial Nejat Düzgüneş Of the 2210 gene therapy clinical trials reported until July 2015, only 115 were carried out by the use of cationic lipid-mediated transfection or “lipofection” [1]. Some trials (387) employed plain plasmid DNA. Most of the trials utilized viral vectors, including adenovirus, adeno-associated virus, vaccinia virus, retroviruses and lentivirus, since they are considered […]

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Commercial Insight – February 2016

Alan Boyd, Mark Curtis & Rahul Sarugaser Providing a critical overview of the sector’s commercial developments – M&As, licensing agreements & collaborations, financial results, IPOs and clinical/regulatory updates, with commentary from our Expert Contributors. CELL THERAPY: After a prolonged process, Astellas was successful in bringing its takeover bid of Ocata to a close this past […]

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Clinical Trial Insight: Cell and Gene therapy Q1

Alexey Bersenev Dr Alexey Bersenev, Yale University, USA, provides an expert overview of the most important clinical trials, cases and cohort studies conducted in academic and industry with particular focus on later-stage efficacy data. DOI: 10.18609/cgti.2016.007 Citation: Cell Gene Therapy Insights 2016; 2(1), 19-22

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Cell and Gene Therapy World

Emily Culme-Seymour, Alexey Bersenev & Colin Lee Novick CONFERENCE INSIGHT On January 28, 2016, the National Oceanic and Atmospheric Administration announced that the January 22–24 snowstorm that hammered the US Eastern shoreline, was a Category 4 (or “Crippling”) on their Northeast Snowfall Impact Scale and that it was also the fourth largest to impact the […]

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Characterization of Rhesus Macaque lung-resident multipotent stromal cells

Ryan W Bonvillain, Michelle E Scarritt, Nicholas C Pashos, Deborah E Sullivan, Aline M Betancourt, Fern Tsien, Ayesha P Umrigar, Andrew M Hoffman and Bruce A Bunnell Research Article Current lung regeneration strategies focus on the airway epithelium, pulmonary endothelium, and their putative progenitors; however, the supportive pulmonary stroma has been widely overlooked. Tissue-resident multipotent […]

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Spotlight on the cell & gene therapy manufacturing pathway

Spotlight Article

The Cell & Gene Therapy Manufacturing Pathway: Part 1

Chris Mason & Elisa Manzotti Foreword The cell and gene therapy sector has recently seen an influx of investment and interest from Big Pharma and venture capital companies, in part due to the promising early clinical data from immunotherapies such as CAR T cells and engineered T cells. However, a number of key questions and […]

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Evolving product attributes through the lens of MSC translation

Spotlight Article

The Cell & Gene Therapy Manufacturing Pathway: Part 1

Robert Deans EXPERT INSIGHT Mesenchymal stem cell therapeutics have entered the home stretch for market approval, with academic and corporate sponsors reporting mid- to late-phase clinical results which will be highly impactful on commercialization of this product class. How well have translational expectations been borne out? Are there lessons learned from a retrospective perspective that […]

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Drivers and methodologies for making cell therapy process changes

Spotlight Article

The Cell & Gene Therapy Manufacturing Pathway: Part 1

Gregory Russotti EXPERT INSIGHT Cell therapies are a new and exciting modality with the potential to treat a variety of severe unmet medical needs. Although the types of cell therapies currently in clinical development encompass a wide range of cell types with various functions, they all can be classified as highly complex biological products that […]

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Centralized or decentralized manufacturing? Key business model considerations for cell therapies

Spotlight Article

The Cell & Gene Therapy Manufacturing Pathway: Part 1

Nicholas Medcalf expert insight The choice of manufacturing strategy for cell-based therapeutics is one that is best made early in product development. Expense and delay may result from any additional bridging studies following changes to manufacturing process design late in development. The chosen strategy will be strongly influenced in turn by the preferred business model. […]

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Translational cell & gene therapy collaborations: accelerating time to market

Spotlight Article

The Cell & Gene Therapy Manufacturing Pathway: Part 1

Cindy Collins INNOVATOR INSIGHT In recent years, cell and gene therapies have moved out of the realm of science fiction and now seem within reach. Indeed, they have made remarkable progress as novel medicines for effective, personalized treatment of some of today’s most difficult diseases, extending the potential and promise of precision medicine. In addition […]

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Toward a scalable and consistent manufacturing process for the production of human MSCs

Spotlight Article

The Cell & Gene Therapy Manufacturing Pathway: Part 1

Qasim A Rafiq Future leader perspective The development of novel, affordable and efficacious therapeutics will be necessary to ensure the continued progression in the standard of global healthcare. With the potential to address previously unmet patient needs as well as tackling the social and economic effects of chronic and age-related conditions, cell therapies will lead […]

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Key considerations in optimizing pluripotent stem cell bioprocessing

Spotlight Article

The Cell & Gene Therapy Manufacturing Pathway: Part 1

Iwan Roberts future leader perspective In the same paper in which the first successful derivation of human pluripotent stem cells was reported, they were already being postulated as a potentially unlimited source of cell transplantation material [1]. In the following years, an entire research field has evolved to seek ways to control and harness the […]

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