BioPharm International-11-01-2008

There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.

Translate the concepts in to practical applications and reduce waste.

FDA perspectives on specs and effective control strategies.

If Indian biologics manufacturers can establish a track record for recombinant products, enhance quality image, maintain cost competitiveness, and demonstrate technology transfer and regulatory knowhow, they are likely to be in the middle of the next boom in biologics manufacturing.

The FDA and other regulatory authorities are evaluating new regulations to ensure the safety and quality of nanomaterials in biomedical products.

Despite creating plastic waste, the disposables option is better for the environment.

A top-10 list of critical legal issues that biotech start-ups should make an effort to address, even when the capital squeeze is intense.

Interview with David Radspinner, director of global marketing & customer applications, bioprocess production at Thermo Fisher Scientific.

Well-designed experiments can reduce the risk of coming to an incorrect conclusion during a process characterization, assay validation, or process validation study.

Supplemental tables for the above-mentioned article, providing additional information about the application of operational excellence methods.

When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.