Krista Alvin, Jeffrey Ly, Russell Condon, Gregory Keil, Xiaodun Mou, Ph.D., Jianxin Ye, Ph.D., David Pollard, Ph.D., Rachel Bareither
The biotechnology and pharmaceutical industries continue to face pressure to reduce the time from discovery to product launch and minimize the costs associated with manufacturing and process development.
Michael W. Dong, Ph.D., Davy Guillarme, Ph.D.
High performance liquid chromatography (HPLC) is the premier analytical technique used in many pharmaceutical applications including potency/purity/performance assays, pharmacokinetics/bioanalytical testing, purification, high-throughput screening (HTS), in-process control (IPC) monitoring and quality control (QC) testing [1-6]. The pharmaceutical industry is the major consumer segment of HPLC [7] and has been the primary driving force for higher throughput and performance.
Tim Sandle, PhD
Microbial identification places an important role in pharmaceutical processing. Microbial identification can be defined as “microbial characterization by a limited spectrum of tests pre-chosen and appropriate to the problem being studied” [1]. Characterizing a microorganism can provide important information as to its origin and potential impact in relation to a product or in relation to the environment in which it was isolated.
Microbiologists should understand the quantity and the types of microorganisms present in pharmaceutical ingredients, water for pharmaceutical use, in-process materials, final product and the manufacturing environment.
Ting Wang, Kristine M. Alston, Carl R. Wassgren, Ph.D., Linas Mockus, Ph.D., Ann Christine Catlin, Sudheera R. Fernando, Sumudinie Fernando, Prabir K. Basu, Ph.D., Stephen W. Hoag, Ph.D.
Under the U.S. FDA’s 21st-century Quality Initiative, formulators are encouraged to use the Quality by Design (QbD) approach to develop robust formulations and processes [1]. The adoption of QbD principles by the pharmaceutical industry has led to growing awareness of the profound influence that variability in excipient properties can have on
quality and product consistency of finished dosage forms. Accounting for excipient variability is an essential part of the risk assessment needed to define the design space [2].
Anthony Cundell, Oliver Gordon, Nick Haycocks, Joe Johnston, Michelle Luebke, Neil Lewis, Jeanne Mateffy, Jeffrey W. Weber
The development and implementation of an online water bioburden
analyzer (OWBA) offers the potential to improve pharmaceutical water
system operations, reduce costs, and ensure water quality. An OWBA
is not intended to eliminate, but rather to reduce compendial water
testing. The overall concept of an OWBA is comparable to an online
total organic carbon (TOC) system, i.e., an online analyzer that provides
real-time bioburden monitoring data and process control feedback
capability. An OWBA can be a risk reduction tool, providing business
benefits through the following measures:
Johannes Kiefer, Ph.D., Kristina Noack M.Sc., Alfred Leipertz
Raman scattering spectroscopy is a standard tool in most analytical
chemistry laboratories and it is an established method for speciation,
structural analysis, and quantification of pharmaceutically active
compounds
Julie T. Adamson, Ph.D.
Within the pharmaceutical industry, the particle size distribution (PSD)
of an active pharmaceutical ingredient (API) may have a significant
impact on both the manufacturability (flowability, packing properties,
mixing, etc.) and quality attributes of the drug product (dissolution
rate, bioavailability, content uniformity, etc.) [1, 2]. Throughout drug
development, it is important to understand how particle size of an API
impacts drug product performance and manufacturability; therefore,
an appropriate analytical method is required for obtaining quantitative
information on particle size distribution.
Homogeneity of a preclinical dose formulation refers to the uniform
distribution of a test article in a vehicle, whether suspended in a liquid
vehicle (suspension), dissolved in a liquid vehicle (solution), or mixed as a
solid into a solid, dietary-type vehicle (solid). Assessment of homogeneity
is a requirement referred to in the GLP regulations 21CFR Part 58, Section
58.113 Mixtures of articles with carriers.
Traditional mycoplasma detection methods involve direct culture
and indicator cell culture techniques. Combined, these two methods
represent what has been termed the “gold standard” in mycoplasma
testing.
Laura L. Parks, Ph.D., was appointed President of DSM
Pharmaceuticals, at DSM Pharmaceutical Products, the
contract manufacturing organization group of DSM N.V. on
June 1, 2102. Dr. Parks has held numerous positions in the
life sciences industry including pharmaceuticals and food &
nutrition for over twenty years.