Justin Pritchard, Martin Warman
Combined physical and chemical characterization of pharmaceutical particles is important to delivering quality drug products. While a number of particle characterization techniques are available, these techniques are limited in that they typically provide either chemical or physical information, not both.
James Akers, Ph.D., James P. Agalloco
Aseptic processing has become a diverse manufacturing technology, which is to say that there are at least three major means of accomplishing an acceptable outcome.
Michael P. Lynch
The initial focus of container closure testing centred on the containers compatibility with the drug product, ability to accurately deliver the dose and maintain sterility. With the development of a multitude of formulation and container closure combinations, the risk posed by container closures is no longer considered “basic” evolving to focus on the role of packaging components and their interaction with the drug product.
Jingshun Sun
Fast chromatography and green chemistry have been the most compelling trends in today’s pharmaceutical industry. Supercritical fluid chromatography (SFC) is one of the few separation technologies that can meet both ‘fast’ and ‘green’ expectations. Since it was first demonstrated in 1962, SFC has advanced remarkably [1]. The fundamentals of SFC including theory and instrumentation have been well established.
Christoph Saal
CS: In my opinion there is not one single trend in solubility technology.
As we have answered the “simple questions” on solubility
measurements getting more data on solubility using generic, technical highor
mid-throughput approaches in recent years, now the more individual
questions gain importance.
Angela Kantor, Serguei Tchessalov, Ph.D., Nicholas Warne, Ph.D.
Biotechnology drug substances are often stored frozen. This approach has several advantages but is also expensive and time consuming. In the development of freeze-thaw processes for protein based products, we sought to develop a framework according to the principles of Quality by Design (QbD).
Anthony Iarriccio, Ph.D., Abe Kassis, Tarun Patel
Of all of the tests that we perform on pharmaceutical dosage forms, perhaps the most important, certainly the most physically taxing, is the dissolution test.
Scott Sutton, Ph.D., Donald C. Singer
The field of pharmaceutical microbiology is responsible for many key objectives in ensuring patient safety and product quality. Quality control, method development, process and product design, and product stability are a few of the objectives. The United States Pharmacopeia (USP), other global pharmacopeias and some parallel industry specific compendia offer some standardized test methodologies and material specifications relating to microbiological quality and control. However these test methods assume significant operational knowledge on the part of the laboratory practitioner and significant operational capabilities of the laboratory itself.
John Kauffman, Ph.D., Jason D. Rodriguez, Ph.D., Dr. Lucinda F. Buhse, Ph.D.
Raman spectroscopy has become a workhorse [1-3] technology in the pharmaceutical industry, and new applications are emerging rapidly. Many of these applications involve the use of Raman libraries for material identification and verification. Raman spectroscopy differs in several important respects from absorbance spectrometry.
Angela K. Goodenough, Ph.D.
Proteins and peptides are widely used as biomarkers of disease state, as drug targets, and as biotherapeutics. Multiple MS approaches have been developed for the quantification of proteins, but often suffer from challenges such as extensive sample preparation, long chromatographic run times, and poor selectivity and/or sensitivity.
Susan Dana Jones, Thomas C. Ransohoff
In the pharmaceutical and biotechnology industry, single-use components originated in medical practice to reduce transfer of infectious material from one patient to another. More recently, single-use products have been developed and implemented by the industry for production of biopharmaceuticals. Disposable single-use filters, buffer bags, and final bulk product storage containers gained rapid market penetration and acceptance, while single-use bioreactors for cell culture, single pass TFF systems for harvest, and disposable options for downstream processing are only recently achieving widespread use.
John B. Cannon, Ph.D.
Orally administered water-insoluble drugs have become increasingly important in therapy, and lipid-based drug delivery systems have become an essential tool in the development of formulations for these compounds.
Ravi Kalyanaraman, Ph.D., George Dobler, Michael Ribick
Pharmaceutical industry and federal agencies are finding ways globally to counteract the increasing threats caused by pharmaceutical counterfeiting [1].
Donna K. F. Chandler, Ph.D., Dmitriy V. Volokhov, Vladimir E. Chizhikov, Ph.D.
“The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.”