Quality/GMPs

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.

QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.

Key considerations for defining your overall control strategy.

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.

Do we really have to choose between saving money and saving time?

Drug counterfeiting has become a major problem for the FDA today; a variety of solutions is needed.

The FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of several Genzyme products: Cerezyme, Fabrazyme, Myozyme, and Thyrogen, which are supplied as lyophilized powders requiring reconstitution before administration; and Aldurazyme, which is supplied as a liquid solution. The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process, and could potentially cause serious adverse events in patients.

What football and bioprocessing both have in common is that in both cases, success is a minimum requirement.

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

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

Conducting a FMEA analysis is a good first step in a risk-based approach for determining the need for a filter integrity test.

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

To make lasting change, you must first win the hearts and minds of the people on the shop floor.

A step-by-step approach is essential for successful implementation.

Automated in-line dilution can help solve capacity, financial, and quality concerns that biopharmaceutical manufacturing plants may be facing.

It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.

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

To assess current trends in cleanrooms and engineering & facilities, BioPharm International turned to Parrish Galliher, founder and chief technology officer, Xcellerex, Inc.; Jim Maslowski, owner, PDC Aseptic Filling Systems; Morgan Polen, vice president, application technology, Lighthouse Worldwide Solutions; and Benoît Verjans, commercial director, Aseptic Technologies.

If risk assessments only identify "the usual suspects," the process will not add much value.

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

ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.

A better method for trend analysis than CUSUM and control charts.