Articles in this Issue
Girish Malhotra, PE
In recent years in the United States there has been news about ever increasing drug prices and essentially ineffective calls/pressure and votes to lower them.
Karen Zink McCullough, Radhakrishna Tirumalai, Ph.D.
The first mention of depyrogenation in the United States Pharmacopeia can be traced back to an informational chapter that appeared in the Fifth Supplement to USP 20-NF 15 entitled, “Sterilization and Sterility Assurance of Compendial Articles."
Rodolfo J Romañach, Adriluz Sanchez Paternina, Kim H. Esbensen
Near infrared spectroscopy is today used widely to monitor mixing of excipients and active pharmaceutical ingredients in pharmaceutical manufacturing.
Amanda Bishop McFarland
When it comes to environmental and critical utilities monitoring, industry agrees that robust investigation and corrective actions are needed following recovery of objectionable organisms.
Wai Ma, Vincent Plassat, Dr. Ronak Savla, Kevin Li
With the increase of molecules in development classified by the DCS as Class II and Class IV, simple formulation approaches like tablets, or powder in a capsule, can lead to suboptimal patient outcomes due to poor oral bioavailability and high pharmacokinetic variabilities.
Stefanie Wohlrab, Michael Wiedmann, Marion Aschner, Dietmar Reusch, Patrick Bulau, Markus Haindl
During manufacturing of biopharmaceuticals prokaryotic and eukaryotic protein expression host systems like E. coli and CHO cells generate a heterogeneous mixture of the desired therapeutic protein and a variety of endogenous HCPs with different physicochemical and immunological properties.
Katherine Macchiarola, Detlef Beckers, Joerg Bolze, Thomas Degen
This white paper explores a number of ways that today’s modern, laboratory-based PXRD instrumentation and advanced software can greatly assist pharmaceutical scientists in their quest to develop high quality, stable products and accelerate their speed to market.
Paula Peacos
Environmental monitoring is a tool utilized by the pharmaceutical industry to measure and monitor microbial bioburden levels in a manufacturing facility.
Susan Neadle, Imre Vàradi
Creating and delivering safe and effective products that reliably meet our customers’ needs, to improve patients’ health and quality of life, is central to health care industry objectives.
Krunal K Mehta, Ryan Soderquist, Pranali Shah, Nick Marchand, Glen R. Bolton
Protein A chromatography has been used as the mAb capture step in the majority of FDA submissions. A recent review article on Protein A resin highlighted the advances in Protein A performance over the last 40 years, focusing on improvements in their capacity, productivity, and operational velocity.
Brian J. Arey, PhD
Within pharmacology we recognize several classes of receptor that are defined by their structure, function and signaling mechanisms: G protein-coupled receptors, nuclear hormone receptors, receptor tyrosine kinases and ligand-gated ion channels.
Anvit Vasavada, M.S., Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in November-December, 2017.