Articles in this Issue
Larry Wigman, Ph.D., Travis Remarchuk, Ph.D.,, Stephen R. Gomez, Ph.D.,, Archana Kumar, Ph.D.,, Michael W. Dong, Ph.D.,, Colin D. Medley, Nik Chetwyn, Ph.D.
Ensuring the purity and high quality of drug substances is a critical
aspect of drug development and patient safety. Organic impurities are
described in international guidelines
David P. Elder, Ph.D, Christoph Saal, Ph.D.
Lipinski’s seminal paper on experimental and computational (in silico) methods to estimate the solubility and permeability of drug candidates
was published just over 15-years ago.
Tony Butler, John Stover, John Shyu, Ph.D., Dr. Nick Hutchinson, Todd Kapp, Dr. Jeri Ann Boose, Cynthia Hoy, Ph.D., Mark Stramaglia, Donald Young
1. What advances in the biotech industry
have allowed for the implementation of fully
disposable facilities?
Jason D. Rodriguez, Sergey Arzhantsev, John F. Kauffman, Lucinda F. Buhse, Manju M. Johny, Steven K. Skaggs, Hirsch K. Srivastiva, Yvette L. Loethen
The increasingly globalized pharmaceutical supply chain [1-3] has
the potential to expose consumers to adulterated or substandard
pharmaceutical materials. Recent adverse events involving the
economically-motivated adulteration of heparin [4] highlight the need
to use modern analytical equipment [5-7] to assist in screening and
surveillance of incoming raw materials including active pharmaceutical
ingredients (APIs). The U.S. Food and Drug Administration Division
of Pharmaceutical Analysis (DPA) has built a spectral library, [8, 9]
containing 500+ entries, for the surveillance of incoming excipients,
APIs, and finished drug products.
Claudio Denoya, Ph.D.
Technological development in microbiological instrumentation has
been progressing at an accelerated rate and with a level of sophistication
difficult to predict just a few decades ago. However, today’s
microbiological quality control laboratory still uses fundamental tools
that were initially developed centuries ago. Why are instruments such
as inoculation loops, broth tubes and Erlenmeyer flasks, agar plates,
incubators, autoclaves, and microscopes still so popular, while many
new detection and enumeration devices applicable in alternative and
rapid microbiological methods struggle with adoption?
Zhibing Zhang, Ph.D., Michael Adams, Ph.D
Pharmaceutical tablets are produced by compacting feed particles
consisting of active ingredients and excipients.
Mino R. Caira, Ph.D.
Physicochemical characterization of solid materials generated in any
program of drug discovery and development is an essential requirement
aimed at ensuring reproducibility in the preparation of a given phase
and on-going monitoring of its integrity during scale-up, processing,
manufacture, formulation and storage [1, 2]. Among the numerous
techniques available for solid-state characterization, powder X-ray
diff raction (PXRD) plays a pivotal role due to its non-destructive nature
and its ability to produce a unique pattern for any given crystalline
phase. Such a pattern (Figure 1), represented as a plot of diff racted
X-ray intensity (absolute or relative) versus the angular parameter 2?,
is viewed as a ‘fi ngerprint’ of the phase in question and a signifi cant
feature is that, unlike the three-dimensional, fully resolved X-ray
diff raction pattern obtained from a single crystal of the same material,
the PXRD pattern of a polycrystalline sample is a one-dimensional
record of diff racted intensity as a function of diff raction angle.
InMotion Autosamplers are more than just sample changers. When
developing the InMotion platform, laboratory workflows and
handling needs were thoroughly evaluated across all segments,
including pharmaceutical labs. The obvious advantage to an
InMotion Autosampler is the number of samples that can be analyzed
at once. Other features, such as the LED status light on the top of
the towers, help increase productivity by notifying an operator if the
autosampler is: still in operation, ready for more samples, or needs
operator interaction.