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Scalability of the Mobius CellReady Single-use Bioreactor Systems

April 2, 2013

Review the process-design space and scalability of a single-use, stirred-tank bioreactor.

Custom-Cell Products: Diversified In Vitro Models

April 1, 2013

The author outlines the need for custom-cell products.

Translating Stem Cells From Laboratory to Clinic

April 1, 2013

Ontario-area scientists discuss approaches to development of stem-cell therapies.

Analytical Method Lifecycle: A Roadmap for Biopharmaceutical Development

April 1, 2013

The authors propose a roadmap for analytical lifecycle development.

Increasing Lyophilization Productivity, Flexibility, and Reliability Using Liquid Nitrogen Refrigeration–Part 1 of 2

November 1, 2007

Protein Therapeutics and the Regulation of Quality: A Brief History

October 1, 2007

Regulatory agencies have evolved along with the biotechnology industry to define quality standards.

The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional Vaccines

August 2, 2007

In animal studies, we have demonstrated that the dose of an injected H5N1 vaccine candidate can be significantly reduced by using a skin patch containing E. coli heat-labile enterotoxin (LT) applied over the injection site. LT-activated epidermal Langerhans cells migrate to the nearby draining lymph node and enhance the immune response to the injected antigen. A dry patch formulation has been optimized as a dose sparing strategy for pandemic flu and other vaccines. Iomai Corporation has developed a proprietary stabilizing formulation for the patch that allows use and storage at ambient temperature. The patch withstands temperature extremes during shipment, and is suitable for stockpiling.

Cancer Vaccines: Asymptotically Approaching Product Approval

August 2, 2007

For many cell-based vaccines, the precursor monocytes or CD34+ cells are cultured with cytokines to obtain dendritic cells, which are very potent antigen-presenting cells (APCs).

Manufacturing Vaccines in Adherent Cell Lines Using Disposable Multi-tray Bioreactors

August 2, 2007

The recent growth in the vaccine market has led to renewed interest in using adherent human cell lines for vaccine production. Traditionally, small-scale adherent cell line production has been carried out in roller bottles or T-flasks. Over the past few years, however, a number of companies have found multi-tray disposable bioreactors an effective method for producing high-quality drug products using adherent cells. These disposable, expandable systems have also facilitated scale up from laboratory to clinical-scale.

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