Analytics

The authors discuss the analysis of the resulting data, focusing on methods for the calculation of mass median aerodynamic diameter, one of the metrics routinely used for comparative testing.

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

The authors describe the benefits of nuclear magnetic resonance (NMR) compared with traditional monitoring techniques. They also discuss how NMR reaction monitoring provides a new process analytical technology tool for industry.

Continuous manufacturing is increasingly noted as an important long-term objective for the pharmaceutical industry. PTE talks with Tim Freeman, Director of Operations at Freeman Technology, about some of the central issues involved in this transition, as well as the supporting role of relevant analytical technology.

Recent recalls have contributed to the pharmaceutical industry?s heightened awareness of glass delamination (i.e., the formation of glass flakes in a vial), which could affect drug quality and patient safety. To confront this growing problem effectively, drugmakers must understand its causes.

The authors summarize a recent FDA–PQRI workshop on process drift.

Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.

New product reviews for October 2011 focusing on analytical instrumentation.

The authors summarize the Matrixx Initiatives, Inc. v. Siracusano case's implications for industry.

This risk-management case study focuses on assessing empty capsules.

GE Healthcare, the health business of General Electric, will dedicate $1 billion of its total R&D budget during the next five years to its technologies for manufacturing biopharmaceuticals and for cancer research. Part of the money will go toward expanding the company's cancer-diagnostic and molecular-imaging capabilities, as well.

Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.

The International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.

Powder Systems Ltd's (PSL's) new GFD™ isolator combines the latest innovation to provide a high containment lab scale filtration and drying solution with the same reliability and benefits as PSL high containment production size filter dryers.

The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.

Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.

Might European officials reverse their position on acceptable production methods?

Industry buy-in is increasing as pharma companies proceed with select projects and research.

New product reviews for September 2011 focusing on manufacturing.

The third in a series of eight case studies from the Product Quality Research Institute focuses on facility biocontainment and inactivation.

By providing an information "fingerprint", infrared red spectroscopy is a useful tool for identifying counterfeit pharmaceuticals. The authors identify best practices for ensuring compliance.

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

The author examines sample-preparations methods used in inductively coupled plasma–optimal emission spectroscopy for four test metals.

We try to use previous experience to develop the optimal granulation process for each new ingredient, but we sometimes get it wrong. Many times, we?ve taken materials from the granulator only to find that they exhibit poor flow and insufficient density. How can we easily determine the end point of a given granulation process?

A firm grasp of probability and ongoing re-evaluation are key.

A book about developing quality-control training manuals provides a wealth of information and a dearth of practical help.

The second in a series of eight case studies from the Product Quality Research Institute focuses on functional equivalence for equipment.

This study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.

Thomas P. Layloff describes the advantages of using thin-layer chromatography methods for counterfeit detection. This article contains bonus online material.