Articles in this Issue

• Analytical Method Development in the Quality by Design Framework

  Dennis Åsberg, Anders Karlsson, Jörgen Samuelsson, Krzysztof Kaczmarski, Torgny Fornstedt
  This article presents a case study describing the development of a pharmaceutical quality control (QC) method using high-performance liquid chromatography (HPLC). Use of ultrahigh-performance liquid chromatography (UHPLC) allows the method to be improved throughout its lifetime.

• Bioprocessing Roundtable

  The biggest trend is that bioprocessing is going smaller scale. With so many blockbuster drugs coming off patent, large pharma companies purchasing smaller biotechs, and greater focus on orphan drugs to remain profi table, the large production facilities to produce one product line are nearing extinction.

• Drug-Excipient Compatibility for the Formulation Development of Solid Lipid Nanoparticles

  Anne Trivino, Harsh Chauhan, Ph.D
  Solid lipid nanoparticles (SLN) are a type of a carrier system that employs solid lipids as a matrix for drug delivery. The drug is molecularly dispersed within the lipid matrix, and the system is stabilized with an emulsifier. Nanoparticles distributed within the matrix usually have a mean particle size between 50 and 1000 nanometers.

• An Application of Rapid Detection Technologies in a National Regulatory Laboratory Setting:...

  Bei Ma, Linbo Wang
  As a result of enormous economic and technological changes in the international trade, globalization has been the new norm over the last few decades. U.S. FDA-regulated products account for about 20% of all imports into the United States, originated from more than 200 countries and territories and pass through more than 300 U.S. ports.

• Successful Sterility Test Failure Investigations—A Practical Approach

  Kenneth H. Muhvich, PhD
  The intent of this article is to provide practical advice based upon gaps that the author has observed during investigations into numerous sterility test failures.

• USP Monograph Modernization Initiative

  Leonel M. Santos, PhD, Behnam Davani, PhD, Clydewyn M. Anthony, PhD, Jon. E. Clark, MSc
  The modernization of United States Pharmacopeia (USP) monographs continues to be a priority initiative. The traditional model has been modernization of monographs through submissions by external sponsors. USP continues to welcome submissions by sponsors. However, USP is also using internal monograph modernization supported by its global laboratories to expedite this process.

• What Patients Need

  Larry Wigman, Ph.D.
  It is easy to lose sight of the patient with all the distractions in the pharmaceutical industry—including meetings, committees, policies, inspections, career paths, timelines, and budgets. However, focusing on the patient is not only a noble goal, but an excellent business strategy. My career in health care started late in the last century as an after-school job in a retail pharmacy. Much to my dismay, the pharmacy did not sell candy bars, magazines, soda, or hair care products. It was a professional pharmacy located in a small medical center at the foot of a major university campus.