Development

The FDA is expanding postmarketing safety requirements, despite limited resources to manage these added responsibilities.

An effective CAPA plan provides a mechanism for responding to the unexpected.

Design of experiments is a valuable tool for identifying aspects of a formulation that are critical to product quality.

The new Sentinel system aims to expand access to data on medical product safety and patient effects.

Sufficient process history is key to the rapid transfer of your process.

Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.

One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.

The two-one-sided t-test compares the equivalency of two data sets.

How will implementing Quality by Design strategies affect your compliance status?

Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.

The nimbleness of biotechs makes them well suited to implementing QbD. Here's how to get started.

Regulatory flexibility can make continuous improvement possible.

A new analysis highlights growth opportunities and challenges for contract development and manufacturing organizations.

Second in a three-part series that discusses the complexities of QbD implementation in biotech development.

Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.

Process performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes.

The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.

Heightened attention to product safety issues is slowing the approval process for new therapies.

This alternative to column chromatography is suitable for flow-through as well as bind-and-elute purification operations.

STIC allows polishing to be carried out without an interstitial dilution step, which reduces process time and avoids additional buffer preparation and hold steps.

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.

The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases.

A case study in capturing indirect costs and benefits.

Pressures to reduce healthcare spending generates proposals to spur competition, cut costs.

A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.