Article - BioPharm International

ADVERTISEMENT

Article

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).

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.

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.

Vaccine Characterization Using Advanced Technology

August 2, 2007

With the advent of high-resolution mass spectrometers and highly sensitive MS instruments, vaccine characterization has entered a new phase.

Pandemic Flu Preparedness: A Manufacturing Perspective

August 2, 2007

For pandemic vaccine processing, single-use filter cartridges and membrane chromatography technologies could offer significant time- and cost-reduction advantages.

Patents: Patent Strategies for Biotechnology Enterprises

August 1, 2007

Companies in the biotech industry typically require one or several partners as they complete the product development cycle.

China Today: Biopharmaceutical Exports

August 1, 2007

In 2006, China exported a total of $890 million in biologics to other countries—a 30.61% increase, compared with the previous year.

Biotech Manufacturers Face Competition from "Similar" Follow-Ons

August 1, 2007

The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.

ADVERTISEMENT

ADVERTISEMENT

Click here