Nigel Smart, Ph.D.
Through the use of a variety of diagnostic tools it is possible to
demonstrate performance in terms of a snapshot in time and then
to trend this over a given period to provide a measurement of
how well you are doing both in terms of performance output and
quality improvement.
Xue Liu, Ph.D., Fernando J. Muzzio, Ph.D., Johannes G. Khinast, Ph.D., Benjamin J. Glasser, Ph.D.
Fluidized beds are extensively used in the pharmaceutical and
other chemical industries either as a batch or continuous process
for drying moist powders and granular solids. This is due to good
mixing of solids and intensive heat and mass transfer between the
solid and hot gas phases in the system. Generally, high energy input
is required during this process to provide the latent heat of water
evaporation, and thus on-line measurements become important to
determine the optimal operation conditions in order to minimize
energy usage.
Anastasia Lolas
Recent bioprocessing contamination events, warning letters and
consent decrees have demonstrated yet again that microbial control
is indispensable in pharmaceutical drug manufacturing operations.
Biopharmaceuticals or therapeutic protein products are derived
from recombinant DNA and hybridoma technology. The protein is
produced by fermentation of media supplemented with nutrients
using mammalian cells, bacterial or yeast organisms. The protein is
then harvested and purified. The resulting bulk drug substance is
stored refrigerated or frozen. Additional modifications or purification
may be performed to the protein drug substance prior to sterile
filtration and aseptic fill that produce a sterile drug product for
patient administration. Low bioburden must be maintained from cell
harvest and recovery up to sterile filtration to assure product quality
and satisfy regulatory commitments and compliance requirements
[1, 2]. The fermenting cell culture must remain pure to produce the
desired protein and yield. Bioburden and other contaminants must be
prevented in subsequent harvest/recovery and purification operations
to meet the low bioburden claim and assure purity, potency and safety.
Ana Sofia Simaria,Ph.D, Dr. Suzanne Farid, Sally Hassan, Ph.D.
The commercial success of allogeneic (universal donor) cell therapies
for large patient numbers is dependent on the development
of scalable GMP manufacturing technologies that can produce
very large amounts of cells in a robust and cost-effective manner.
Prochymal (Osiris, Columbia, MD, USA) for graft-versus-host disease,
approved in Canada and New Zealand, and Cartistem (Medipost,
Seoul, Korea) for osteoarthritis, approved in South Korea, are
examples of current commercialized allogeneic stem cell therapies.
Nevertheless, several notable failures due to manufacturing
concerns such as high cost of goods (COG), high process variability
and loss of efficacy upon scale-up have been reported [1-5]. This
article investigates the potential of planar expansion technologies
to meet potential commercial cell therapy demands.
Marc Tesconi, Ph.D., Margaret S. Landis, Ph.D
Aqueous solubility is an important aspect of pharmaceutical drug
development. Very often structure-activity relationships of small
molecule pharmaceuticals are tuned to maximize aqueous solubility
to facilitate in vivo delivery of the drug substance. Solubility is also
important in the synthesis, crystallization and purification of the
drug substance. Aqueous solubility consideration is paramount to
understanding results from in vitro biological testing of efficacy and
planning for formulation approaches to conduct pharmacokinetic and
toxicological screening. Lastly, but often not highlighted, is the fact
that aqueous solubility is vital to understanding the long-term impact
of pharmaceuticals in our environment. The content of this article
was presented as a pre-conference workshop at the IQPC 7th Annual
Improving Solubility Summit.
Gregory P. Martin
Dissolution is the primary pharmaceutical test that is designed
to probe the performance of dosage forms. From its beginnings
in the middle of the twentieth century to address some serious
issues with products on the market [1], the scope of application
has grown to include use as a tool for formulation selection during
product development and as a tool to enable waivers of bio-studies
[2,3] under certain circumstances. Naturally, a dissolution test
should be well suited to its intended purpose, but the purpose
may be different depending on the circumstances. The purpose
of this article is to provide some insight into the development of
dissolution tests for pharmaceutical dosage forms for several of the
most frequent intents.
Emil W. Ciurczak, Ph.D.
2013 is, for me, an auspicious year. It marks the 30th anniversary
of looking into a new technique for raw materials qualification
and finding, ta-da, near-infrared spectroscopy. There were few
choices of vendors in the US at that time: the company with whom
I worked on my research which no longer exists (thanks to venture
capitalists), and the other major player, which has, over the years
morphed into a leading manufacturer of instruments for chemical
analysis and is still doing quite well. My company was developing
qualitative software at that time.
Tseng-En Hu, Ph.D., Elie Chaaya, Zhihao Lin, Ph.D., Chuck Orella, Ph.D.
Process Analytical Technology (PAT) has been extensively applied to
the manufacture of pharmaceuticals (drug products) and the typical
choice of PAT platforms is principally spectroscopy, based mostly on
the speed of analysis, ease of sampling, and operational simplicity.
In the manufacture of drug substance, selectivity and sensitivity of
the analytical platform are important for better characterization,
understanding, and purging of impurities. HPLC (or UHPLC) is
ubiquitous in laboratories (engineering, analytical and quality), and
the regulatory compliance structure (quality system, SOPs, method
transfer, etc.) for common tests is well-established. Also important
is the proficiency of staff in the choice of technology for method
transfer to a commercial-scale supply site.
The pharmaceutical industry is going through a transformation, so SPX designs our dryers to satisfy the demands of the modern pharmaceutical industry. All the easy soluble drug entities have been discovered and now the researchers must go after the rocks, which are insoluble drug substances.