Articles in this Issue
The pharmaceutical industry has been relying on the use of planar and static cell cultures in well plates for a century now. These monolayer cell-based models are instrumental to drug screening as they provide extremely high throughput allowing for simultaneously testing of hundreds to millions of compounds through established automation in handling and analyses, which are further downsized for subsequent animal experimentation before moving to the costly and time-consuming multi-phase clinical trials.
Developments in real-time measurement technologies for bioburden applications are providing tangible benefits in the biopharmaceutical industry. Benefits include increased agility and efficiency to support decision-making, aid in the identification of elusive root causes, and enabling development of risk mitigation strategies among others. This article shares a case study in which a rapid micro- biological methodology (RMM) was leveraged as a tool to support a forensic evaluation for recovery of environmental conditions in a manufacturing facility after an unplanned business disruptive event.
Finding a trusted laboratory services provider in the pharmaceutical industry can be a daunting task. It is often difficult to find a service provider that offers the right mix of technical experience, breadth of capabilities, global reach and regulatory expertise. Eurofins Lancaster Laboratories, headquartered in Lancaster, Pennsylvania, is such a company with optimal capacity and expertise to assist bio/pharma companies with their analytical testing needs.
Tony Cundell, Ph.D.
As a consultant I have received questions from colleagues as to whether the Chinese Pharmacopeia (ChP) microbial test methods are equivalent to the U.S. Pharmacopeia (USP) methods. Frankly, I was at a loss as how to answer this question.
The modern microbiology laboratory is a complex system of inputs and outputs that culminate in a decision being made about the quality or suitability of a product based on the data collected. This is just one reason that it’s so important for modern laboratories to adopt behaviors and policies that encourage a strong stance on data integrity, as data is the backbone of all the decisions we make as microbiologists.
Eileen Cortes, EIT, MBA
When we talk about pharmaceutical and biotech drugs an immediate image of patients, brands and labels comes to mind; but it is less common, at least for those who do not work in the industry, how complex it is and how every day there is a battalion of professionals protecting the integrity and safety of those products.
Dean Erhardt
Drug prices have come under attack from consumers and payers, with President Trump now focused on the issue and tasking pharmaceutical companies to respond with better pricing. To date, pharma companies have struggled to address these concerns, but are meeting with little success.
Emil W. Ciurczak, Ph.D.
As a consultant, I have gotten calls where the potential clients states, “I’ve just purchased a NIR instrument; could you tell me what to do with it?” Assuming they do not hang up when I do tell them what they can do with it, I explain the problem(s) associated with “putting the cart before the horse.” But, first, we will examine the plethora of kinds and sizes of NIR spectrometers.
Dr. Steven S. Kuwahara
In recent years the subject of Data Integrity has become important mainly because of the many deficiencies that have been discovered by pharmaceutical inspectors and auditors around the world. Although Data Integrity is an old and basic issue in all types of manufacturing, the results of inspections and audits have revealed inconsistencies in the way that the subject is interpreted and applied in different regions and countries around the world.
Anvit Vasavada, M.S., Amitkumar Lad, PhD, Sunny Christian, MS, 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 May-June 2018.
Microbial identification can be performed with different technologies, which have different capabilities for differentiating closely-related species.