Drug Development

New product reviews for December 2011, focusing on manufacturing.

Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry.

Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria.

A Q&A with Deborah Tanner, executive vice-president and group president of R&D laboratories at Covance, on recent industry trends.

Readers react to the economic turmoil of the past year and look longingly forward to 2012.

Pharma companies must balance demand for new drugs while facing reduced R&D spending.

The last in a series of eight case studies from the Product Quality Research Institute focuses on internal GMP audits.

The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.

Small drug companies with hopes of achieving $1 billion in sales can pursue various strategies.

Pharmaceutical companies are responding to the high cost of introducing new drugs to market in different ways.

Researchers develop various catalytic approaches for improving yield, purity, stereoselectivity, and process conditions.

Novartis AG and Novartis Pharmaceuticals Corporation have been focusing research efforts on rare diseases since the company was established in 1996.

The study evaluates near-infrared analysis of tablets nominally containing 4 mg of chlorpheniramine maleate and 10 mg of phenylephrine hydrochloride per dose.

The authors describe the operational qualification of test accuracy with regard to temperature drift using a thermal-compensation algorithm on several freeze dryers.

June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.

Combining olfactometry analysis with multidimensional gas chromatography–mass spectrometry provides an extremely useful analytical method for identifying aroma or odor notes from a sample.

A Technical Forum Moderated by Patricia Van Arnum, featuring contributions from PerkinElmer, BioTools, Chiral Technologies, Shimadzu Scientific Instruments, GE Analytical Instruments, and Waters.

The authors investigate the effect of low pH and ionic strength on aggregation using turbidity measurements and size-exclusion–high-performance liquid chromatography.

View presentations from the 2011 winners of AAPS Scientific Awards.

When I run a small production batch of a particular formulation with the same tablet press used to develop it, I get compressibility and disintegration issues. What am I doing wrong?

John Kelly, vice-president of strategy and transitioning sites for Pfizer Global Supply, discusses the company's manufacturing and supply strategy and network.

The authors experiment with a resonant acoustic mixer as a method for dry powder coating.

Average deal size and amounts invested increased in the second quarter, but totals trail funding of last year.

AAPS Global Health Focus Group's Kishor M. Wasan discusses new initiatives.