Outsourcing

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

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

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.

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.

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

Despite the current regulatory uncertainty, pharmaceutical companies should move forward with planning for serialization and pedigree.

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

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

The bioinformatics industry is currently one of the fastest growing fields in India's biotechnology sector. Indian IT companies have several advantages in the bioinformation field and can continue to grow their opportunities worldwide.

It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.

Most local and global clinical research organizations (CROs) consider an operational presence in India as key to their overall business plans. India is clearly on course to become the next hub for clinical trials.

The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity.

Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.

A decision-criteria matrix and cost models helped pinpoint the best distribution approach for the short- and long-term.

There are several considerations to keep in mind when auditing an outsourcing provider.

The outsourced service provider should be considered an extension of your own laboratory.

After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements.

When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision.

There are several steps that you can take to ensure that you get the greatest benefit from consultants.

The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.

Now is a good time for companies to know their suppliers well.

The supply base for preclinical and clinical development services continues to expand in China.

India is restructuring its regulation of biopharmaceuticals to help the country's industry compete internationally.

How an electronics engineer led the first Indian company to carry out indigenous development of a recombinant vaccine.

The cause of the heparin crisis is still unknown. We do know, however, that the FDA is severely underfunded.

Indian biogenerics could form a major piece of the global biotherapeutics market in the future.

A CMO faces significant risk of lost revenues and profits if the product fails in clinical trials or doesn't meet sales projections.

How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.

China's pharma industry represents 5% of the world total. By 2010, China is expected to become the world's fifth largest pharmaceutical market.