Mark A. Petrich, Ph.D.
Single-use systems (SUS) promise many benefits to the biopharmaceutical
industry including reduced cross-contamination risks, lower capital
investment, elimination of cleaning and sterilization operations, reduced
turnaround times, and the ability to scale an operation up or down with
limited additional investment [1,2]. SUS are provided in a sterile, readyto-
use format, or as non-sterile parts for user processing.
Gary Ritchie, Mark Sullivan, Ph.D., Brian Marquardt, Ph.D., Claudia C. Corredor, Ph.D., Robert Chimenti
how does the movement from lab-based
instruments to portable tools in the industry
bolster pat?
Kelly Zhang, Ph.D.,, Jenny Wang, Midco Tsang, Larry Wigman, Ph.D., Nik Chetwyn, Ph.D.
The interest in two-dimensional HPLC (2DLC) in pharmaceutical
analysis has been increasing quickly in recent years as illustrated by
recent journal publications and presentations at analytical conferences.
Although two-dimensional separation technology and theory was
introduced more than 30 years ago [1-3], the liquid chromatography
applications were mostly in proteomics, natural products, biological
samples and polymers, and were limited in pharmaceutical analysis
until recent years
Angel Tan, Ph.D., Clive Prestidge, Ph.D.
Lipid-based drug delivery systems are developed to mimic the food
(or post-prandial) effect to address the oral bioavailability challenges
of low solubility drugs and vitamins. That is, the molecules are
effectively solubilized in the lipophilic microenvironment generated
by the presence of fat and their corresponding digested fatty acid
products mixed with endogenous micellar components.
María Esperanza Ruiz, Ph.D.
Dissolution testing has become a fundamental and indispensable tool
for the evaluation of the in vitro quality of solid oral dosage forms, and
as such is accepted as a critical factor worldwide.
Michael J. Miller, Ph.D.
For more than 30 years, the field of alternative and rapid
microbiological methods (RMMs) has influenced the application
of novel technologies across a number of industry sectors. In fact,
much of the development of new instrumentation, software and
analytical methods for the detection, enumeration and identification
of microorganisms has been driven by consumer and patient needs
within the food, beverage, environmental and clinical or health care
industries.
Jodi M. Zobrist, Nicole W. O’Brien, Ph.D.
Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the
increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma
industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for
smaller, more agile biomanufacturing capacity.
Beth Brescia
Water is a key raw material utilized in the manufacturing of products within the pharmaceutical,
biopharmaceutical and healthcare industries. Within each industry, regulatory requirements exist
for microbial contamination in different levels of water purity. The microorganisms found in these
water systems are mainly stressed, slow-growing strains characterized by long incubation times (5
to 7 days) before growth can be detected using traditional microbiology methods. The time required
before contamination can be detected in water may cause delays in product release, and extend
the storage time of products. By using rapid detection methods, manufacturers are able to address
contamination events sooner, avoid line shutdowns, release product to the market faster, and reduce
warehousing costs.
Mark Shon
Given significant costs of producing a freeze-dried product (including equipment, utilities, etc.) along
with the desire to decrease development timelines to get products on the market faster, reducing
cycle development times and shortening the drying cycles are two significant financial drivers in
today’s industry.
Bree Allen
In the manufacturing of today’s pharmaceuticals, the introduction of Raman spectroscopy has
created a paradigm shift in how quality inspection is performed. Once considered a new and
unproven technology, Raman instruments have since evolved into the handheld, battery operated
analyzers now in use around the globe, in high-volume, for a variety of material analysis applications.
As word spreads about the efficiency gains achieved with the use of handheld and portable
Raman, pharmaceutical companies are no longer wondering ‘if’ they should implement Raman
instrumentation, but instead are determining which Raman instrument is best-suited for their unique
production environment.
Michael Dotlich, M.Sc., Richard M. Kattner, M.Sc., Robert Roginski, Ph.D., Jeremy Shaver, Ph.D
A placebo-controlled study is a means of testing a drug for safety and efficacy
in a group of subjects that receive the treatment. Current placebo identity
tests typically utilize an HPLC identity method for the active compound to
confirm the absence of the active (i.e., negative identity). In this review, the
development and application of transmission Raman spectroscopy (TRS)
with chemometric modeling for positive placebo identification testing will
be applied to drug products, illustrated for several compounds and their
respective placebos.
T.N. Thompson
Freeze-drying consists of three major process stages: freezing, primary drying (sublimation), and
secondary drying. Primary drying is the longest stage of the freeze-drying process. Most of the eff ort
for process improvement has focused on measuring and controlling the product temperature as
close to its critical point as possible to shorten the cycle. However, to produce a better product in a
shorter period of time the focus needs to be on developing a suffi cient pore size and uniformity in
the frozen product. Producing a better ice crystal structure, using an optimized freezing protocol, can
result in both higher yields due to more uniform cake structures and shorter primary drying cycles
due to reduced cake resistance.