Process and Scaling

Many factors affect research results.

In any industry, inspections can be a pain, and pharma is no exception.

The need for greater process understanding raises the bar for suppliers.

The author provides an overview of QbD implmentation for biopharmaceuticals.

Just when things seem to be looking up, the unexpected problem occurs.

Taking care to note, file and re-check information can save one from future mishaps.

The authors highlight the need for a technology-transfer process that is efficient, cost-effective, and repeatable, stressing the importance of process understanding. Read this and other preferred organization articles in this special issue.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

Sometimes doing what you think is right ends up being completely and utterly wrong.

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

This article examines the difficulties in designing lyophilisation processes that can be faithfully scaled up to production volumes and suggests the most effective ways in which this can be achieved.

From disagreement to denial, being cordial about quality control can be challenging.

The authors present three approaches that a contract development and manufacturing organization can consider when designing development and process-optimization studies that will provide useful data for scaling up a project.

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.

The authors discuss a continuous-flow reactor that avoids parallel channels and enables economic plant setup. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

Reports of overlooked controls, dropped pallets, and misplaced documents leave a chill in the air.

Too much or too little control can actually lead to the same result.

When vessels, seals, and cooling units go haywire, operators must get in the mix.

A Technical Forum featuring representatives from Dow Chemical, ISP, and DMV-Fonterra Excipients. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

If you’ve worked in the drug industry for a while, chances are good that you remember Pfizer’s Rezulin, which was produced through hot melt extrusion (HME). If you work for a major pharmaceutical manufacturer, it’s likely that your company owns a twin-screw extruder. Yet HME has not been a common way of manufacturing drugs, and many industry employees don’t understand the principles of HME or the advantages that the technique offers.

Laboratory personnel share interesting tales as well as stories of unexpected tails.

Continuous manufacturing could bring the pharmaceutical industry advantages such as improved product quality, easy scale-up, flexibility, and short cycle times. But how can a company switch from batch to continuous manufacturing?

From last-minute product inserts to putting out fires, close calls are a common occurrence.

Sharing too much-or too little-information can have disastrous onsequences.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

References for the article published in the February issue of Pharmaceutical Technology Europe.