There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Articles

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.

Inhaled Product Characterization

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

Protein Sensitivity to Tungsten

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.

NMR Reaction-Monitoring as a Process Analytical Technique

Tim Freeman is Managing Director of powder characterization company Freeman Technology for whom he has worked since the late 1990s. He was instrumental in the original design and continuing development of the FT4 Powder RheometerÂ® and through his work with various professional bodies, and involvement in industry initiatives, is an established contributor to wider developments in powder processing.Tim has a degree in Mechatronics from the University of Sussex in the UK. He is a mentor on a number of project groups for the Engineering Research Center for Structured Organic Particulate Systems in the US and a frequent contributor to industry conferences in the area of powder characterisation and processing. A past Chair of the American Association of Pharmaceutical Scientists (AAPS) Process Analytical Technology Focus Group Tim is a member of the Editorial Advisory Board of Pharmaceutical Technology and features on the Industry Expert Panel in European Pharmaceutical Review magazine. Tim is also a committee member of the Particle Technology Special Interest Group at the Institute of Chemical Engineers, Vice-Chair of the D18.24 sub-committee on the Characterization and Handling of Powders and Bulk Solids at ASTM and a member of the United States Pharmacopeial (USP) General Chapters Physical Analysis Expert Committee (GC-PA EC).

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.

Under Continuous Consideration

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.

Steps for Reducing Glass Delamination

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

Quality Issues for Multiregional Clinical-Trial Materials

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

FDA/Industry Perspectives: Detection, Measurement, and Control in Manufacturing

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

OOS, OOT, OOC, and OOSC

New product reviews for October 2011 focusing on analytical instrumentation.

In the Spotlight October 2011

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

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes