By Nate Taninecz, Senior Director of Product Management at Model N
I recently had the pleasure to participate in a panel discussion at the 2013 HDMA Contracts and Chargeback conference, held at the historic Hotel Du Pont in Delaware. For two days, industry thought leaders educated the attendees on the challenges of the day. There was one particular theme that was a conference highlight, and at the forefront of most attendees’ minds: 340B.
By Seth A. Mailhot, Special Counsel, Sheppard Mullin Richter & Hampton LLP
On June 14, 2013, the FDA issued the guidance "Codevelopment of Two or More New Investigational Drugs for Use in Combination." The guidance discusses the FDA's recommendations for developing an entirely new combination therapy where none of the drugs to be used in combination have been previously developed.
By Kelly Williams, Market Analyst
Headlines involving laboratory safety issues are not making the national news agencies, so the general population, as well as laboratory personnel, are not aware of the number of incidents that are actually occurring in laboratories. Lack of proper training certainly plays a role in these incidents, but most importantly, it is a lack of daily compliance to safe laboratory practices. Noncompliance is easy when you are not aware of the consequences. Because we are not hearing of these "lab incidents," it is easy to take shortcuts and not consistently follow standard lab protocols that ensure our safety. Constantly hearing about horrific traffic accidents keeps us clicking our seatbelts, so maybe if we were more aware of actual cases where negative consequences occurred because of lack of safety compliance we would make it a higher priority.
By Bruce McDuffee, Marketing Manager, Vaisala Life Science Division
If you're in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that must comply with current good manufacturing practice (cGMP), your facility will be inspected by the U.S. Food and Drug Administration (FDA).
The percentage of aggregates in bacteria cultures may be determined by employing the Coulter Principle, also known as the electrical sensing zone (ESZ) technique. The ISO International Standard 13319 describes this technique.
By Kevin Zarnick, Thermo Fisher Scientific
Using metal detection as a means of identifying foreign object contamination has been prevalent in the food industry for decades. Although metal detection has also been in use to identify the presence of ferrous, nonferrous, or stainless-steel contaminants during the past 40 years in the pharmaceutical industry, it has not been as widespread.
By Giuseppe Bonfiglioli, Bonfiglioli Engineering SPA
Production of tablets and capsules is carried out in cleanrooms, and under stringent procedures, as per GMP requirements. However, the process also relies on machines and machine operators, whereby misappropriate handling can result in a faulty blister pack containing microleaks in the packaging that allows air and moisture to enter the blister and damage the product.
By Robert McGregor, Global Marketing and High-End Product Manager, Brookfield Engineering Laboratories, Inc.
You bet it does, whether or not manufacturing realizes it. Rheology is the science that looks at how materials flow. Whether the product is a liquid, cream, paste, or solid, the manufacturing process must transfer raw ingredients through multiple stages to create the finished product.
By Kelly Williams, Labconco Corporation
The process of finding the right fume hood can be a little complicated if you don't know the right questions to ask. You can save yourself a lot of trouble if you know the answers to these questions when you start shopping.