Articles in this Issue
Zheng Lu, Reza Fassihi
In recent years, many scientists in the pharmaceutical industry are
focusing part of their research activity on the development and use
of oral strip technology (OST).
Jeremy Peters, Anna Luczak, PhD, Varsha Ganesh, Eugene Park, Ravi Kalyanaraman, Ph.D.
Counterfeit drugs pose a significant and fast-growing threat to
public health and safety. The incident of counterfeit Avastin® in the
United States demonstrates the vulnerability of the supply chain
even in developed countries. Government health agencies and
pharma-ceutical manufacturers are finding ways to fight counterfeit
and substandard drugs by identifying them from manufacturing,
throughout the supply chain, and eventually when they reach the
public in the retail pharmacies.
Nigel Walker
Moving into 2016, the outlook for outsourcing is brighter than ever as
pharmaceutical and biotechnology companies continue to rely more
heavily on external service providers for research, development and
manufacturing services. According to a new 2016 Nice Insight CRO
and CDMO Outsourcing survey of 1,173 industry representatives from
pharma and biotech companies, spending for outsourced services
takes a big leap compared to previous years.
John Morrison, PhD
Contemporary small molecule therapeutics are often hindered by
poor physicochemical properties, with high lipophilicity and/or
crystallinity leading to poor aqueous solubility. This in turn limits oral
absorption resulting in low or variable systemic exposure. While the
concept of poor solubility is well understood, a practical definition
is more complex. The USP-NF defines several categories of solubility
limits. For instance, the lowest category deems a compound to be
practically insoluble/insoluble if the solubility is less than 0.1mg/mL
in water.
Peter Tattersall, Suwimon Asawasiripong, PhD, Ivone Takenaka, PhD, John A. Castoro, PhD,
Forced degradation studies (FDS) are essential in the development
of stability indicating methods to gain understanding of the intrinsic
stability characteristics of a Drug Substance (DS). Performance of stress
studies under various conditions allows prediction of the possible
degradants that may be obtained during registrational long term
stability studies (LTSS). These degradants are used to develop and
validate the selectivity required for registrational DS and drug product
(DP) analytical methods. New molecular entity registrational filings
require discussion of forced degradation data in stability indicating
methods (SIM) validation and degradation mechanistic stability
sections along with any relevant controls in both synthesis and the
formulation sections of the Health Authority dossier submission.
Paula Peacos
Quality risk management (QRM) is a systematic process for the assessment,
control, communication and review of risks to the quality of a
product or process over the entire product lifecycle. An effective QRM
program can ensure high quality of a given process or product by
providing a proactive means to identify and control potential quality
issues during development and production. QRM can also improve the
quality of decision making. (ICH Q9 2005).
Substantial advancements in lyophilization technology have occurred
in the last five years namely as a result of research related to the
lyophilization process and the incorporation of this knowledge into
development tools and equipment design. These advances have
resulted in new ways to approach product development or product
remediation. One particular example is the use of Manometric
Temperature Measurement (MTM) technique during the lyophilization
process to accurately determine product characteristics such as product
temperature at the sublimation interface, dry layer thickness, product
resistance, sublimation rate and other important data across a product
batch under certain process conditions.
M. Jason M. Jason, Philip M. Potter
Carboxylesterases (CE) are ubiquitous enzymes that metabolize
ester-containing compounds into the corresponding alcohols and
carboxylic acids. This is primarily thought to be a detoxifi cation
process for xenobiotics since the proteins are principally localized in
cells and tissues likely to be exposed to such agents. However, ester
chemotypes signifi cantly improve the water solubility of molecules
and hence the strategy of including these functions in poorly soluble
drugs is widely employed in the pharmaceutical industry.
Tim Sandle, PhD
Cleanrooms and clean areas must be regularly cleaned and disinfected.
This is normally undertaken using a detergent step, followed by the
application of a disinfectant. It may be necessary to remove the residue
of the disinfectant using water. Cleaning and disinfection should also
extend to equipment. Furthermore, with personnel, sanitization is
important in relation to glove hands.
Consumable or single-use operating costs will far exceed
the initial capital investment, so do not lock yourself into
a single-source situation, especially on the bag fi lms and
tubing sets. Qualify at least two vendors for each unit
operation of your processes to ensure security of supply
chain and price. Consider using “universal controllers”
for each unit operation to facilitate the interchange of
bioreactors, fi lters, and chromatography columns