Centered on the promise, “we make the best perform better,” ANGUS
brings more than 70 years of experience in the nitroalkanes space,
offering many unique and proprietary chemistries for a wide range of
markets including life sciences, personal care, paints & coatings and
metalworking fluids. ANGUS was recently acquired by Golden Gate
Capital, bringing a renewed commitment to ANGUS’ offerings and
services through investment in research and development, expanding
our staff of experts, and strengthening customer relationships.
Allison Scott, PhD
Modern technologies that enhance process knowledge and process
control have been developed for use in pharmaceutical manufacturing.
The adoption of such technologies has been encouraged
in guidance such as FDA’s 2004 Guidance for Industry on Process
Analytical Technology (PAT), and the adoption of Quality by Design
(QbD) principles. Rapid Microbiological Methods (RMMs) are a
subset of such technologies permitting the rapid detection of
microorganisms, in contrast to traditional culture-based methods in
use in the pharmaceutical industry for the past century. One class of
RMM instrumentation utilizes intrinsic, laser induced fl uorescence (LIF)
to detect the presence of microorganisms in air or water. It provides
results in real-time, enables continuous monitoring, and doesn’t
require stains or reagents for detection. As applied to pharmaceutical
water quality, this method of instantaneous microbial detection off ers
enhanced process control across a number of applications through its
real-time and continuous bioburden monitoring capabilities.
Our viral clearance guarantee is a way for us to show our clients that
we believe in our product. After designing the study to meet the
expectations of our client and determining the level of viral clearance
that we can obtain based on preliminary testing, we will achieve the
agreed-upon level of clearance or we will perform additional testing at
no cost.
James Mitchell, David Elder, Ph.D.
Lipinski’s influential paper on strategies to assess solubility and
permeability of drug candidates was published nearly two decades
ago1. The ‘Rule of 5’ demonstrated that exposure was negatively
impacted if the calculated LogP (cLogP) was >5,
Chunang (Christine) Gu, Baiwei Lin, Joseph Pease, Nicholas Chetwyn, Peter Yehl
In spite of the great progress made in research and development to
combat severe diseases such as cancer, rheumatoid arthritis, high
blood pressure, and aging-associated diseases, the drug development
process itself has become increasingly complex and expensive. On
average, it takes approximately ten to twelve years and $1.4 billion to
bring a new drug to market.
Raymond Nims
The use of a PCR and sequencing based
cytochrome c oxidase subunit 1 (CO1)
barcode assay for establishing the species level
identity of animal cells is discussed
below.
Maura C. Kibbey, Robert G. Bell
A validated biological manufacturing process includes the demonstration
that the process adequately removes or inactivates potentially
known or unknown viral containments. The International
Conference on Harmonization (ICH) Q5A guideline, Viral Safety
Evaluation of Biotechnology Products Derived from Cell Lines of Human
or Animal Origin, describes the viral safety testing and evaluation of
biotechnology products derived from human or animal origin that
should be submitted within the biological registration package. ICH
Q5A discusses complementary approaches to control potential viral
contamination; however, the ICH guideline lacks specificity on how to
conduct and perform appropriate viral clearance studies and has not
been revised since 1999.
Francis Flanagan, Brian Kozlowski, Erin Hein, Gary Romberger, Minh Do
Drug products for pediatric patients are typically formulated as
powder for suspension, oral granules, oral solutions and most recently
mini-tablets. In the past, most pharmaceutical companies deferred
pediatric formulation development long after the adult product had
been marketed, with this work mainly driven by receiving additional
market exclusivity in major markets. However, agency expectations
make it mandatory for pharmaceutical companies to communicate a
pediatric formulation assessment for new pharmaceutical products,
which often leads to pediatric formulation development activities
even prior to application of the adult formulation.
Ralph Lipp, Ph.D.
Today, more than 2500 medical entities are approved in the United
States alone and more than 4000 on a global scale1. Still, there exists
notable unmet medical need, which is being addressed by significant
investments into the development of various kinds of innovative
medicines. This has led – among other things – to the approval of 41
new medical entities by the FDA in 20142. In addition, dozens of mature
drug delivery technologies are available today, and a substantial
number of novel ones is under current development.
Kaoru Tominaga, Beverly Langevin, Edward Orton
The importance of hot melt extrusion (HME) technology in the
pharmaceutical industry is evident in the wide range of drug products
that are currently marketed (Table 1). HME is utilized to produce various
drug delivery systems such as pellets, granules, tablets (immediate
and modified release), oral fast dissolving systems, transdermal and
transmucosal delivery systems, transungual delivery systems and
implants.
Cheryl Platco
The use of purified lipopolysaccharide (LPS) as a surrogate contaminant
for natural endotoxin currently remains a controversial and
misunderstood subject. Soon after the FDA published a questions and
answers document1 stating that firms should establish the stability
of assayable endotoxins in their products, mixed interpretations of
how to achieve this requirement occurred. This was especially true for
products containing no measurable endotoxin.
Mark Severns
Ensuring product sterility is critical to patient health and safety.
Sterility testing is an essential procedure as part of pharmaceutical
manufacturing, and can be one of the most time-consuming quality
tests. The test, typically 14 days in length is often a bottleneck in the
manufacturing process. Final products cannot be released until all
QC testing, and particularly the sterility test is complete. In certain
manufacturing environments, such as vaccine production, sterility
testing is required during manufacturing, creating delays.
Tim Sandle, PhD
Biological and biotechnological products
are at risk from chemical impurities, bacteria
and fungi, and from viruses. With such
products the potential for transmission
of viral diseases is a real risk. With viral
contamination, contamination can affect
raw materials, cell culture processes,
bioreactor contamination and downstream
processing. It is for these reasons that
pharmaceutical organizations need to practice
viral safety and incorporate virus
clearance into the manu-facturing process.
Galina Holloway, PhD, Catherine Sheehan, MS, MS, Hong Wang, PhD
The objective of the USP initiative is to develop standards that
refl ect state-of-the-industry techniques for suffi ciently monitoring
drug quality, purity, and strength. USP has made steady progress
in updating outdated methodologies in the USP–NF through
collaborative eff orts with FDA and its stakeholders.
Dhavalkumar Narendrabhai Patel, Lirui Qiao, Jimmy Yuk, Kate Yu
In recent years, there has been a tremendous increase in the use of natural
products in the form of herbal supplements for health benefits and
therapeutic effects. Unfortunately, this rise in usage has also led to the
increased chance of products being adulterated with synthetic compounds
by unscrupulous manufacturers. There have been reports of severe to
even fatal cases
related to adulteration in herbal products. This has raised
global concerns within the natural products community and with various
regulatory authorities since it poses a significant risk to consumers.
Packaging components used in pharmaceutical drugs and medical devices are scrupulously cleaned before use to ensure patient safety. Regulators expect drug manufacturers to demonstrate compliance with federal requirements intended to assure clean, sterile and safe drug products enter the medical marketplace. Depyrogenation, the reduction of bacterial endotoxin, is critical in preparing packaging components for use in injectable drug products.
Emilie Branch, Kshitij ‘TJ’ Ladage, George Tsiolis
As the biologics industry continues to grow exponentially, marked
by an increase in Biologic License Applications (BLAs) submitted for
approval, the focus of big pharma has begun to shift towards the
need for cell therapeutic specific drug development. The expansion of
pharmacogenetics is shaping the current industry trajectory into the
world of personalized medicine. Pharmacogenetics holds much promise
because it not only removes the uncertainty from the drug selection
process, which is the main challenge when prescribing, but also
potentially offers expedited recovery time and reduces the likelihood
of adverse reactions.
Scott Sutton, Ph.D.
Environmental Monitoring (EM) generates a large amount of data.
Even relatively small programs can generate hundreds of data points,
however, raw data is not useful until it has been analyzed and yields
information. This is a key question that must be addressed: How can we
extract information from a mound of EM data? Trending of the EM data
is one way that FDA recommends extracting the relevant information
and this short review will look at different methods to trend data from
an operational perspective. That is to say, we will first establish the
purpose and goals of the EM program and then discuss how trending
of the EM data supports that program with relevant information.
XRPD is a powerful tool in the pharma industry because of its capability
to help researchers identify crystalline structure of materials, identify
phases that are present, distinguish between polymorphs, and even
elucidate structure in amorphous materials. Proving that a new
chemical entity (NCE) is indeed a novel structure is critical to patent
positioning. Additionally powder diffraction measurements can be
made under non-ambient conditions (temperature, humidity, etc) such
that material stability can be tested under extreme conditions. And
most applications of XRPD are non-destructive in nature, leaving the
sample intact for further investigation by other techniques.
Roman Galeev, Bei Ma, Anatolyi Saveliev, Arislanov Ilshat
Substandard and counterfeit medicines remain an urgent problem for
not only developing countries but also countries with well-established
rigid regulatory systems for the pharmaceutical market. The
development of rapid and non-invasive spectroscopic technologies
using Raman and Near Infrared (NIR) has become an effective way to
combat such substandard and counterfeit medicines.