BioBusiness

Four reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.

To stave off quality issues associated with production processes, a centralized and enterprise-wide quality management initiative must be enforced.

No time for QbD? How to convince management to make it a priority.

A closer look at the past year's development in India.

The meltdown in the financial markets represents a sea change in the world of financing that will continue to affect the flow of much needed capital into the sector for the foreseeable future.

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.

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.

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.

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.

The country is reeling from US Treasury Secretary Henry Paulson's proposed $700 billion Wall Street bailout. In appealing for support, Paulson stressed this was a crisis. This sense of urgency is reminiscent of the way millions of Americans without health insurance cope with medical problems-in the emergency room, because they have no access to routine and preventive care.

The year 2007 witnessed the approval of fifteen biopharmaceuticals in the United States and European Union.

An analysis of current and upcoming industry challenges.

To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors.

The rapid growth of the pharmaceutical industry in India is yet to create significant changes in the Indian distribution system.

The biotech industry's year-to-date report card contains good grades despite the turbulent economic climate.

There are several challenges associated with protecting patents for personalized medicines.

Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.

Risk mitigation should be a key aspect of any contract manufacturing organization's business strategy.

Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.

What the Indian government is doing to make its biotech sector as strong as its IT sector.

In addition to making technical developments, vendors are also looking at ways to improve supply-chain security. By offering standard, off-the-shelf products, vendors are able to shorten lead times and improve the security of supply.

The US Food and Drugs Administration is boosting its efforts for orphan drugs development.

Best practices a pharmaceutical company can follow to execute their strategy sucessfully.