Articles in this Issue
Nilanjana Das, PhD
Antibody-drug conjugates (ADCs) are a novel class of therapeutic
agents that have widely been investigated for their potential
applications in the treatment of cancer. In simple term, ADCs consist of
a cytotoxic drug (0.3 to 1 kDa) connected by a linker to a monoclonal
antibody (150 kDa), which directs it to the target cancer cells with
abundant cell surface associated antigens.
James Mitchell, David Elder, Ph.D.
It has long been recognized that complete resolution of all components
of a complex mixture is extremely challenging using a single
chromatographic method. In addition, complete resolution of all of
the additional components, i.e. related products or impurities, from the
major peak (the drug substance) is an ancillary challenge.
Reliability, flexibility and cost are three very important
variables. Reliability, from the perspective that a customer can use
the same instrument right across the globe over a 10 year life cycle
(based on 10% depreciation costs/annum). Flexibility, that allows the
customer to purchase (as required) new ‘aligned modules’ to react
to new business drivers.
Ralph Lipp, Ph.D.
Pain affects more patients in the United States than diabetes, heart
disease and cancer combined. Chronic pain in particular impacts
over 100 million Americans.
Maik Jornitz, Russell E. Madsen
Sterilizing-grade membrane filters, commonly used within the
biopharmaceutical industry to sterilize fluids, require validation to
assure these filters function as defined1,2. During validation the chosen
membrane filter commonly undergoes a product bacteria challenge
test under the process conditions specified for the production
process.
Nicolas Drouin, Serge Rudaz, Julie Schappler
Bioanalysis concerns the analysis of xenobiotics (such as drugs) and
endogenous compounds (such as biomarkers) in biological systems.
Both xenobiotics and biomarkers encompass low molecular weight
(LMW) and high molecular weight (HMW) analytes.
Kirti Vatsa, Ken Seufert
Reports of drug shortages surfaced in news outlets in 2010. By 2011,
the number of drug shortages peaked. Of the 251 problem drugs
published by the FDA, 183 involved sterile injectable products (FDA/
CDER Drug Shortage Program).
Tong (Jenny) Liu, Ph.D., Kevin Moore, Ph.D., Catherine Sheehan, MS, MS
The Pharmacopeial Discussion Group (PDG) was formed in 1989 with
representatives from the European Directorate for the Quality of
Medicines in the Council of Europe (the European Pharmacopoeia);
the Ministry of Health, Labor, and Welfare (the Japanese Pharmacopoeia);
and the United States Pharmacopeial Convention (the
U.S. Pharmacopeia).
Guy Tiene, MA
The recovering global economy and continued high demand
for advanced medicines in all regions of the world has provided
pharmaceutical companies with the cash needed to invest significantly
in discovery and innovation for the last several years. That investment
has resulted in very robust pipelines and in part the highest FDA
approval rates seen in some time. The commercialization of these new
drugs will allow this heightened R&D activity to continue.
Archana Kumar, Ph.D.,, Joseph Lubach, Julia Griffen PhD, Jenny Wang, Chi Y. Tsang, Jonathan Hau, Matthew Bloomfield, Pavel Bondarenko, Larry Wigman, Ph.D.
Aqueous solubility and intestinal permeability are two parameters
predicting intestinal absorption. A number of newly developed drugs
belong to Biopharmaceutics Classification System (BCS) Class II or IV
and exhibit poor or no solubility in aqueous environments resulting in
poor bioavailability. Forming an amorphous phase, which can exhibit
much higher dissolution rates in biological fluids compared with its
crystalline counterpart, may enhance bioavailability.