Articles in this Issue

• Freeze-Drying Protein Formulations above their Collapse Temperatures: Possible Issues and Concerns

  Robert Johnson, Ph.D., Lavinia Lewis, Ph.D.
  Freeze-drying is a popular method of prolonging the shelf life of protein drug products, but lyophilization cycles can be long and expensive.

• Where is the Real Value in Applying Single-Use Technology to Clinical and Commercial Manufacturing?

  Rick Stock, Ph.D.
  The answer depends on the resourcefulness and creativity of the end user. Many studies have focused on cost of goods savings (COGS), but development companies, contract manufacturing organizations (CMOs) and large pharmacuetical companies all have their own specific accounting to report these costs.

• Drug Delivery Roundtable

  Alexander Jaksch, Alan Shortall, Sheila Dell, Ph.D., Christian Helbig, Andy Fry, Ryan Hawkins
  AJ: Tighter specifications and glass barrel designs that help avoid glass breakage (i.e. smaller flange). AS: Drugs, particularly biologics, are becoming more novel, specialized and patient-centric. Delivery devices must reflect this. As such, devices are increasingly being customized to meet the specific molecular and dose administration requirements of the target drugs.

• Fast Analytical Chromatography and the Role of the Design of New Stationary Phases

  Fabrice Gritti
  The role of the development of new stationary phases in the last twenty years on the progress made in fast liquid chromatography is discussed based on their speed-resolution properties.

• Process Raman Spectroscopy for In-Line CHO Cell Culture Monitoring

  Justin Moretto, John Paul Smelko, Maryann Cuellar, Brandon Berry, Alex Doane, Thomas Ryll, Kelly Wiltberger
  Spectroscopic methods represent an innovative scheme for the analysis of in vitro processes. Raman spectroscopy offers significant advantages over other spectroscopies for bioprocess monitoring and was evaluated as a means of quantifying chemical changes in a dynamic Chinese Hamster Ovary (CHO) cell culture environment.

• Bioprocessing Methods to Prepare Biobased Surfactants for Pharmaceutical Products

  Douglas G. Hayes
  Surfactants have numerous uses in pharmaceuticals, for solubilization of hydrophobic drugs in aqueous media, as components of emulsion or surfactant self-assembly vehicles for oral and transdermal drug delivery, as plasticizers in semisolid delivery systems, and agents to improve drug absorption and penetration. Many pharmaceutical-grade surfactants consist of saccharide- or polyol-fatty acid esters or fatty alcohol ethers.