By Suzanne Elvidge, Contributing Editor
For pharmaceutical companies, aligning the regulatory strategy across many countries saves time and money for drug developers, resulting in earlier access by patients.
By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Using the instrument maker's tolerance, there is often a higher risk of an "Out of Tolerance" appearing on a calibration certificate; this costs money. Consider the following scenario: You have just received back from calibration the set of temperature sensors used to monitor the warehouse. Most of the instruments have been shown to be within manufacturer-published tolerances. A few of the instruments, though, are listed as out of tolerance. Now the fun starts!
By Dr. Rüdiger Lomb, Global Director, Quality and Technical Compliance, World Courier
This article covers improving compliance and efficiency in the pharmaceutical supply chain with reduced cost and risk. How does the sponsor ensure that product transfer conforms to the same established written procedures demanded at the investigator level throughout the full length of the supply chain, or more specifically, while in the hands of nonpharmaceutical, noninvestigator personnel?
By Scott Szwast, Healthcare Segment Marketing Director, UPS
It has been said that "demographics are destiny," and this is certainly true of the global growth of the middle class. Newly empowered consumers around the world are creating dynamic and expanding new markets for products that promise to sustain and improve the quality of their lives. International trade has become particularly important for pharmaceutical and medical device manufacturers, because 57 percent of demand is now found outside of North America. Foreign markets are also manifesting the fastest growth. Yet less than one percent of U.S. healthcare companies export. What factors hinder pharmaceutical and medical device organizations from participating in the large and growing global marketplace? Many companies cite two primary concerns as the impediment to taking their businesses beyond a solely domestic focus.
By Brad Swarbrick, CAMO Software
As a global leader in the pharmaceutical industry, Wyeth utilizes Global Vision's solutions to help reduce the risk of errors from occurring at key stages throughout the artwork workflow process. As a customer for more than a decade, Wyeth has adopted and benefited from this type of technology early on.
By Amy N. Yoder and Li Liu, Beckman Coulter Life Sciences
Automation with the Biomek 4000 platform can improve the throughput and reproducibility of conventional staining of adherent cells. Applicability is demonstrated using mouse embryonic stem cells (mESCs) to detect the expression of developmental antigens in fixed cells following differentiation to cardiomyocytes, which is relevant to stem cell biology research.
By Brandy Nunez, Brian Canna, MBA, and Jessie Ni, PhD
Irvine Scientific specializes in developing and manufacturing cell culture media for bioproduction. To ensure the utility of the medium, CHO cell lines are tested for density, viability, and productivity.
By Rakesh Bose, Scott Anderson, Kathy Lawrence, and Melissa Wilcox
During pharmaceutical development of biologically active compounds, the identification and purification of unknown impurities is a key requirement for the successful registration of a new molecular entity.
INTERPHEX is the single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms of life-enhancing drugs. See, touch, and procure the latest technologies and innovations March 18 to 20, 2014, at the Javits Center in New York City. For more information visit www.INTERPHEX.com.