Drug Development

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

Critical issues that should be considered when scaling up a hot-melt extrusion process.

Scale-up Challenges in Hot-Melt Extrusion

Failure to disclose info may work sometimes, but eventually every question will be answered.

Loose Lips Sink Ships

In a world where product recalls can mean the end of a company, all batches must be perfect.

Total Recall

With the increasing use of hot-melt extrusion, extruder manufacturers have developed mid-size twin-screw extruders that facilitate process development and scale-up to commercial processes.

Mid-Size Extruders Enable Scale-Up of Hot-Melt Extrusion

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

Shipping with the Enemy?

Technology may expedite operations, but the absence of the human element could cost dearly.

All Systems Slow

Cleanliness is crucial, even if zapping and trapping is necessary to reduce product contamination.

Buzz Off the Product

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.

FDA Notifies Genentech of Violations at Avastin Plant

Careful mixing during a product's distillation can help avert trouble from a strong concoction.

Easy on the Alcohol!

Jerold Martin was the senior vice president of global scientific affairs at Pall Life Sciences and the chairman of the Board and Technology Committee at Bio-Process Systems Alliance.

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.

Process and Scaling