Journal Archive

Expert Insight

Raw materials for cell & gene therapy: exploring regulatory and supply issues

Spotlight Article

Innovator Insight

Cell & Gene Therapy Raw Materials: Getting it Right from the Start

Dr Bernd Leistler

Bernd-Leistler

As Vice President Development & Production, CellGenix, Bernd Leistler is responsible for all products including serum-free media and cytokines for ex vivo cell processing. Bernd has a long track record as protein specialist. Following his degree in chemistry he joined the Basel Biocenter for his dissertation on the structure, function, folding and assembly of oligomeric proteins. He continued these studies as a postgraduate researcher in Cambridge, UK. His professional career started in 1993 at a leading manufacturer of diagnostic autoantibody immunoassays which later became part of Pharmacia Diagnostics. There he managed the Biotechnology Department and developed it as a corporate service unit for recombinant and conventional human autoantigens and allergens.

DOI: 10.18609/cgti.2017.024
Citation: Cell Gene Therapy Insights 2017; 3(3), 183-187.
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Impact of raw & starting materials on the manufacture and regulation of gene & cell therapies

Spotlight Article

Interview

Cell & Gene Therapy Raw Materials: Getting it Right from the Start

Richard A Dennett, Valérie Pimpaneau and François Gianelli

Understanding the definition of raw and starting materials and the impact this has on the regulation and commercialization of your gene and
cell therapies is essential. To help shed light on this critical topic, Cell and Gene Therapy Insights spoke with members of the CMC team (Richard Dennett, Valérie Pimpaneau and François Gianelli) at Voisin Consulting Life Sciences who partner with Biotech, Pharma and Medtech manufacturers to develop, register and launch innovative products in North American and European markets.

DOI: 10.18609/cgti.2017.031
Citation: Cell Gene Therapy Insights 2017; 3(3), 189-195.
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Strategic & practical considerations in raw material selection & sourcing for cell therapies

Spotlight Article

Innovator Insight

Cell & Gene Therapy Raw Materials: Getting it Right from the Start

Dr David Wellis and Dr Robert Tressler

David-Wellis-100x120Rob-Tressler-120x100

Dr David Wellis is a cell biologist with over 25 years experience in the life science industry and currently serves as the CEO of the San Diego Blood Bank (SDBB), which is a member of Blood Centers of America (BCA). David serves as Chair of the Cellular Therapies Leadership Committee within BCA. David joined SDBB following his tenure at a variety of companies that developed tools for biomedical research, diagnostic and applied markets, including Illumina, GenVault and Axon Instruments. David received his B.S. from UC Irvine, an M.S. and Ph.D. from Emory University, postdoctoral training at Tufts University and UC Berkeley, and business training at Leavey Business School of Santa Clara University and Haas Business School at UC Berkeley.

Dr Robert Tressler is Vice President of Laboratories for the San Diego Blood Bank where he oversees the Public Cord Blood Bank and Cell Therapy research program. Previously he held leadership roles in Biotechnology companies, serving as head of Preclinical Oncology Research at Geron, Inc., overseeing their oncology and anti-aging research programs. He also was VP of Research and Development at Cellerant Therapeutics, heading up research and development efforts for stem cell and oncology programs.

DOI: 10.18609/cgti.2017.021
Citation: Cell Gene Therapy Insights 2017; 3(3), 175-182.
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Scope and challenges of managing particulates in cell therapy manufacturing

Spotlight Article

Interview

Cell & Gene Therapy Raw Materials: Getting it Right from the Start

Dr Jean Stanton

Jean-Stanton

Dr Jean Stanton joined Johnson and Johnson (J&J) in 2008 after more than 20 years in the healthcare industry, developing cell-based therapies. Jean is responsible for leading the integration of cell and gene therapy regulations into Janssen’s internal quality standards. Jean works closely with the business and development organization, establishing compliance strategies relating to cell and gene therapy products as well as supporting due diligence activities, regulatory agency interactions and health authority inspections. Jean’s current responsibilities also include the deployment and maintenance of the R&D compliance program for all GMP aspects within the J&J Pharmaceutical sector, which includes the development and maintenance of the quality and compliance strategies to support all novel products that are in-licensed or developed within Janssen.

DOI: 10.18609/cgti.2017.023
Citation: Cell Gene Therapy Insights 2017; 3(3), 165-169.
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Commercial considerations for raw materials in the cell and gene therapy industry

Spotlight Article

Interview

Cell & Gene Therapy Raw Materials: Getting it Right from the Start

Dr Jon A Rowley

Jon-Rowley

Jon A Rowley, is the Founder and Chief Technology Officer of RoosterBio, Inc. Jon started RoosterBio in 2013 as part of his personal quest of having the biggest impact possible on the commercial translation of technologies that incorporate living cells, including cellular therapies, engineered tissues and tomorrow’s medical devices. Jon holds a PhD from the University of Michigan in Biomedical Engineering and has authored over 35 peer reviewed manuscripts and 20 issued or pending patents related to biomaterials development, tissue engineering and cellular therapy. Jon started his industry career at BD as a scientist and R&D manager in a Cell & Tissue Technologies group focused on applying high throughput screening technologies to cell therapy media development and tissue engineering. Jon then contributed to the clinical development of Aastrom Biosciences’ Tissue Repair Cell product, where he was Sr Manager of Process Development responsible for manufacturing process improvements and cell delivery to the patient. Jon most recently spent 5 years as Director of Innovation and Process Development in Lonza’s Cell Therapy CMO business, and currently resides in Walkersville, MD with his wonderful wife and their 3 young children.

DOI: 10.18609/cgti.2017.022
Citation: Cell Gene Therapy Insights 2017; 3(3), 171-174.
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Research Article

Daidzein analog 2l enhances osteogenic differentiation of BMSCs and ASCs seeded on PLGA scaffolds and heals critical size calvarial defects

Research Article

Amy L Strong, Marjorie E Bateman, Robert B Jones, Maria F Dutreil, Annie C Bowles, Isadore M Budnick, Shilong Zheng, Daniel J Hayes, Benjamin Levi, Jeffrey M Gimble, Matthew E Burow, Guangdi Wang, Margaret A McNulty & Bruce A Bunnell

Repair of craniomaxillofacial defects continues to present a significant challenge due to the limited amount of autogenous and allogeneic bone for reconstruction. Significant advances in the development of biodegradable polymeric material and the understanding of adult stem cells will yield new tissue engineering approaches to reduce the burden of craniomaxillofacial defects. Tissue engineering approaches have utilized biodegradable scaffolds in combination with bone marrow-derived mesenchymal stem cells (BMSCs) or adipose-derived stromal/stem cells (ASCs) and growth factors to augment the healing process. While this approach is promising, identification of additional factors that play a role in bone healing may further accelerate the bone regeneration process. The osteoinductive properties of daidzein analogs in monolayer adherent cultures have previously been demonstrated. In the current study, BMSCs and ASCs were seeded on poly lactic-co-glycolic acid scaffolds and treated with daidzein analogs in vitro. Scaffolds seeded with BMSCs and ASCs and treated with daidzein analogs demonstrated enhanced osteogenic differentiation in vitro. Additional in vivo analysis of the daidzein analog was conducted in the critical size calvarial defect model. Calvarial defects treated with scaffolds seeded with BMSCs or ASCs and exposed to the daidzein analog 2l also demonstrated enhanced osteogenesis. Histological analysis of the liver and kidney demonstrated no pathological findings. Collectively, these results suggest that daidzein analogs utilized in combination with biodegradable scaffolds and adult stem cells may be a safe and efficacious combination to promote the regeneration of bone and thus reduce the burden of craniomaxillofacial defects.

Submitted for review: Apr 2 2016 Published: Apr 10 2017
DOI: 10.18609/cgti.2017.032
Citation: Cell Gene Therapy Insights 2017; 3(3), 197-210.
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