Paul E. Luner, Ph.D., Shawn Mehrens
Polymorph and crystal form control is an essential part of development of active pharmaceutical ingredients (API) [1]. Processing steps such
as milling for API particle size reduction or those involved in the solid dosage form processing have potential to alter the input crystal form
and this is often referred to as Process Induced Transformation (PIT). The impact and mechanisms of processing stress on phase transformation
have been well reviewed and examples are provided [2-5]. Although basic physical characterization techniques can be successfully applied
at the API level for form assessment, detection of low levels of different crystal forms within a dosage form on a routine or release basis can require significant effort and can be challenging because of detection limits and specificity
Scott Sutton, Ph.D.
The USP Antimicrobial Effectiveness Test (AET) is a product quality test which is designed to be, so far as is possible, a reproducible biological measurement of the activity of the preservative system in a product. This test is required for multi-dose presentations of pharmaceuticals as well as anhydrous ointments that contain a preservative system [1].
Kevin L. Williams
Since the inception of Limulus amebocyte lysate (LAL) testing [1], the past four decades of testing have proven fruitful in terms of making in-vitro predictions of in vivo responses regarding the significant pyrogen of drug manufacturing, bacterial endotoxin. The Limulus test has served as the basis of preclusion of bacterial endotoxin in drug products
for these many years. However, current discoveries elucidating the mechanisms by which endotoxin interacts with host biosensors in both invertebrates and vertebrates is turning many a preconceived notion on its head.
Cara N. Wilder, Ph.D.,, Tim Sandle, PhD, Scott Sutton, Ph.D.
The human body is a composite of human cells that survive
interdependently alongside complex, interconnected microbial
populations, their genetic elements (genomes), and environmental
interactions.
Michael Pohlscheidt, Goetz Lieser, Bjoern-Erec Bertermann, Horst Eberhardt, Stefan Herter, Hermann Tebbe
Recombinant DNA technology has enabled the industrial production
of monoclonal antibodies and recombinant proteins for targeted
treatments of several diseases such as cancer and viral infections.
George L. Reid, Ph.D., James Morgado, Kimber Barnett, Ph.D, Brent Harrington, Jian Wang, Ph.D, Jeff Harwood, David Fortin
The concepts described in ICH Q8-Q11, commonly referred
to as Quality by Design (QbD), have also been applied to the
development of analytical methods.
Vladimir Torchilin, Ph.D.
Traditional pharmaceuticals rarely demonstrate specific affinity towards the site of their action and as a rule, they distribute throughout the body upon administration. To reach the action site, a pharmaceutical agent has to overcome the inactivating action of the aggressive biological medium and cross a variety of biological barriers, which frequently results in at least partial drug inactivation/degradation and unfavorable pharmacokinetics and biodistribution. In addition,
many pharmaceutical agents could provoke multiple undesirable side effects in normal organs, tissues and cells. To solve these complicating issues, various systems for drug delivery are suggested, and some of those even have already found their way to clinic.
Associates of Cape Cod, Inc.’s (ACC) fourth generation tube reader,
the Pyros® Kinetix Flex, offers the most sensitive bacterial endotoxin
test (BET) available for both turbidimetric and chromogenic kinetic
methods. In addition to flexibility of test method, ACC offers a choice
of 32, 64 and 96 well readers. All of these readers provide the flexibility
to add tubes at any time. Unlike a microplate reader, additional
samples can be added after a test has been started. Also, we shall soon
have an exciting new offering in the area of endotoxin testing.
From a CMO’s perspective, serialization should help prevent fraud
and help DSM as well as its customers’ research any issues reported
downstream in the supply chain. Through serialization and other
technologies like video surveillance, DSM will have the ability to
investigate primary and secondary packaging units to the exact time
they were packaged during a standard packaging run.
Anna Mills
Environmental Monitoring is an essential component to any
microbiological testing regime. Unfortunately, the task is often time
consuming due to the large volumes of tests and the length of time
required for sample capture, processing and incubation of samples.
Reading such high volumes of plates adds an extra time constraint
for the Microbiologist and a risk of human error element. The Growth
directTM System has been designed to cut both the work load and
reduce risk to create a leaner, more efficient laboratory.
Andrew Sage, Ph.D.
The goal of microbial testing is to detect contamination that is
present in, or introduced into sample matrices such as controlled
manufacturing environments (air, surfaces, personnel), waters, and
raw, in-process, and final product materials among many others. Like
any testing application, the methods must be validated to confirm their
effectiveness in detecting microbial contaminants from the particular
sample matrix in question.
Tim Sandle, PhD
There are many pharmacological impurities which can appear,
through unintended routes, in formulated final products. Although
undesirable in terms of not meeting the strict requirements of
a prepared product, the impact upon the drug formulation and
potential impact upon the patient will vary according to the type and
concentration of the impurity.