Articles in this Issue

• Streamlining the Safety Evaluation for the Introduction of Raw Materials for Single-use Systems

  Arn Malliett
  In the current economic environment many companies are more rapidly identifying and implementing cost cutting and cost savings measures. One method of cost savings that has gained traction is the utilization of single-use systems (SUS). Within the biotech-manufacturing sector, SUSs are available as line kits for bioreactors, the bioreactors themselves, filters, and even purification columns are available as disposable or limited use components.

• Rapid Microbiological Methods: Where Are They Now?

  John Duguid, Dr. Ed Balkovic, Gary C. du Moulin, Ph.D., M.P.H
  Microbiological testing is slowly evolving as traditional methods with microorganism detection requiring days or weeks yield to technologies collectively known as Rapid Microbiological Methods (RMM), which may detect the presence of a single organism within hours.

• Identification of Unknown Mixtures of Materials from Biopharmaceutical Manufacturing Processes...

  Gary Li, Wen Jing, Zai-qing Wen, Ph.D.
  Mixtures of unknown materials may be found during the development and manufacturing of biopharmaceutical drug products. Their physiochemical properties must be identified to determine the root cause and to take corrective and preventive actions. Fourier Transform Infrared (FTIR) spectroscopy is widely employed as a powerful analytical tool to obtain the fingerprints of unknown materials in the Mid-IR region.

• The Impact of Elastic Recovery on Near- Infrared Tablet Predictions

  Kevin Macias, Ph.D., Dimuthu Jayawickrama, PhD, Gary McGeorge, Ph.D
  As Real Time Release testing (RTRt) of solid dosage forms is sought, it is necessary to understand and mitigate challenges that might hinder successful implementation of spectroscopic methods. For compressed tablets one such challenge has been to account for the elastic recovery that occurs after tablet compression since tablets used for calibration and validation purposes may have been manufactured in the past and undergone full elastic recovery while the tablets for routine application will be right off the press and may be in various states of elastic recovery.

• Dried Blood Spot (DBS) Evaluation of Compounds with Differing Physiochemical Properties and...

  Roger Pham, Earl Moore, Mary C. Wells, Ph.D., Guifen Xu, Ph.D., Bernd A. Bruenner, Ph.D., Christopher A. Jamesm, Ph.D., Philip Wong, Ph.D.
  Dried blood spot (DBS) collection is a microsampling technique recognized as having several advantages compared to frozen specimen handling, including low blood volume sampling requirements, reduced biohazard risk, as well as lower cost and ease of sample storage and transport. These qualities have increased the attention and application of DBS for pharmacokinetic and toxicokinetic studies in small molecule drug discovery and development.

• Phase Separation of Proteins by Poly-ethylene Glycols: Implications in Preformulation and Early...

  Vineet Kumar, Ph.D., Nitin Dixit, Shubhadra N. Singh, Ph.D, Devendra S. Kalonia, Ph.D.
  Polyethylene glycols (a-Hydroxy-?-hydroxy-poly(oxy-1,2ethanediyl) abbreviated PEGs, are a family of non-ionic synthetic polymers with an empirical formula HOCH2(CH2OCH2)mCH2OH (1).

• Concomitant Use of Near-Infrared Chemical Imaging and Raman Spectroscopy during the Selection...

  Saly Romero-Torres, Ph.D., Rina Chokshi, Ph.D., Jun Huang, Ph.D., Mahesh Krishnan, Ph.D.
  Various manufacturing platforms are often investigated during the development of a solid oral dosage form. The final selection of a manufacturing process is primarily based on ensuring critical drug product quality attributes such as physical and chemical stability, dissolution, active ingredient consistency and integrity, and ease of scalability.