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Mar 15, 2011 (Vol. 31, No. 6)

Status of Cell and Gene Therapy Keeps Vacillating

Recent High-Profile Success of Dendreon's Provenge Has Not Quelled Widespread Skepticism and Skittishness

  • Highlighting Advances in Automation and Stem Cell Culture

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    Thermo Scientific’s Nunclon Vita surface was designed for the growth and expansion of hESCs or IPSCs. It does not require feeder cells or ECM. Expression of pluripotency markers in human ESCs as determined by immunofluorescence staining after 11 passages on Nunclon Vita surface.

    At the meeting, Thermo Scientific featured its Nunclon™ Vita™ energy-treated polystyrene surface for the growth and expansion of human embryonic stem cells (hESCs) or induced pluripotent stem cells (iPSCs) without the need for feeder cells or extracellular matrix.

    The company uses energetic oxidation to induce a chemical reaction in the polystyrene polymer that creates functional groups onto which hESCs can attach and form colonies. A patent-pending method that combines the Nunclon Vita surface and conditioned media containing the Rho-associated kinase inhibitor Y27632 allows for the growth of hESCs for >10 passages and of iPSCs for >3 passages without differentiation or karyotype changes, according to Thermo.

    U.K.-based Angel Biotechnology, which specializes in GMP manufacturing of cell therapies including stem cells, viruses, antibodies, and recombinant proteins, recently announced a new GMP manufacturing contract and a five-year pricing agreement with Russian pharmaceutical company Materia Medica. Angel plans to increase its manufacturing capacity by at least fivefold.

  • Automated Processing

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    CaridianBCT’s Quantum Cell Expansion System is an automated system designed for growing adherent and suspension cells in a closed environment. Based on hollow-fiber bioreactor technology, it allows for large-scale manufacturing of cells under GMP control with a reduced risk of contamination, stable incubation, and continuous cell feeding and waste removal using bags organized above the device.

    CaridianBCT launched the Quantum Cell Expansion System, an automated, closed system that supports the growth of adherent and suspension cells in a hollow fiber bioreactor. Cell loading, media exchange, and cell harvesting are all automated. The seven-minute harvesting step can reportedly yield 0.5–1 billion cells.

    Later this year, Miltenyi Biotec will introduce the CliniMACS® Prodigy integrated cell-processing system. The customized system can process cells from blood or bone marrow, carrying out all operations—from cell washing and density gradient separation to MACS® cell separation and cell harvesting—in a closed environment.

    The Automation Partnership (TAP) designed the CellBase CT cell-expansion system to meet the needs of companies transitioning autologous cell-therapy products from manual to automated processing under GMP conditions to produce quantities needed for clinical and commercial development. The system can maintain up to 90 T flasks under temperature and CO2 control, and provides noncontact media dispensing and flask-to-flask transfer, automated cell count and cell viability analysis, confluence measurements, and barcoding for sample tracking.

  • Leading the Pack

    ReGenX highlighted its recombinant adeno-associated virus (AAV) vector technology for tissue-targeted in vivo gene delivery. The technology can be used to overexpress a gene or inhibit gene expression or activity. Applications include creating animal models of disease and screening therapeutic proteins in vivo. Specific AAV serotypes allow for gene transfer to targeted tissues including heart, retina, brain, lung, pancreas, liver, and skeletal muscle.

    Eufets provides product-development services for cell and gene therapies including process development and scale-up, cGMP contract manufacturing, assay development, quality control, preclinical studies, and regulatory support.

    Advaxis is pursuing multiple Phase II trials in cervical cancer and head and neck cancer for its live-attenuated Listeria monocytogenes vaccines targeting human papilloma virus. The company also has Listeria monocytogenes therapeutic vaccines in clinical studies in breast and prostate cancer and in glioma. The vaccines contain the Listeria monocytogenes virulence factor listeriolysin O, a protein that stimulates an innate immune response and a cytokine response that enhances the function of antigen-presenting cells.

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