Article - BioPharm International

ADVERTISEMENT

Article

Making the Best Choices in Single-Use Tubing

April 2, 2013

Jerold Martin considers the types of tubing available to the industry and how to make an informed selection.

Custom-Cell Products: Diversified In Vitro Models

April 1, 2013

The author outlines the need for custom-cell products.

Analytical Method Lifecycle: A Roadmap for Biopharmaceutical Development

April 1, 2013

The authors propose a roadmap for analytical lifecycle development.

Translating Stem Cells From Laboratory to Clinic

April 1, 2013

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

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.

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.

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.

Regulatory Issues: Pandemic Preparedness Pacing Up

August 2, 2007

Any endpoint considered appropriate to support approval, whether a surrogate or a clinical endpoint, must be supported by substantial evidence of effectiveness.

ADVERTISEMENT

ADVERTISEMENT

Click here