Articles in this Issue

• Standards for the Optical Detection of Protein Particles

  Dean C. Ripple, Joshua R. Wayment, Michael J. Carrier
  Particles in protein therapeutics, composed of aggregated protein monomers, may cause an immunogenic response in patients. Consequently, industry and the FDA desire more accurate methods for counting and characterizing particles. Unlike many manufacturing impurities, protein particles have a refractive index very close to that of the matrix solution.

• Pre-use/post-sterilization Integrity Testing of Sterilizing Grade Filter: The Need for Risk...

  Maik Jornitz, Theodore H. Meltzer
  Sterilizing grade filtration has been used for decades with reliability and assurance. The reliability of this particular aseptic processing step increased with filter stability improvements, robust integrity test methodologies and especially process validation requirements,

• What is the Solubility of My Compound? Assessing Solubility for Pharmaceutical Research and...

  Anna Petereit, Ph.D., Christoph Saal
  What is the solubility of my compound? During research and development phases for drugs, the question is frequently asked, “What is the solubility of my compound?” While at a first glance the answer seems to be just a simple number, it turns out that a useful answer will be much more complicated for several reasons.

• Quality-by-Design for Freeze-thaw of Biologics: Concepts and Application During Controlled...

  Angela Kantor, Shannon MacMillan, Kin Ho, Serguei Tchessalov, Ph.D., Nicholas Warne, Ph.D.
  This article, the second of two parts , continues the discussion of the application of Quality-by-Design (QbD) principles to freeze-thaw and storage of biologics drug substances. Specifically, we focus on the application of QbD to cryo-celsius bag systems (up to16.6 L) as well as cryo-vessels (125 to 300-L).

• Single-use Disposables Technologies in Biopharmaceutical Contract Manufacturing

  William Downey, Helen Nicely, Ph.D.
  Innovative technologies continue to be adopted by biomanufacturers to meet the ever-increasing demands for higher quality, faster delivery, and lower costs.

• Direct Method Scaling from UHPLC to HPLC: Is this feasible for Pharmaceutical Methods?

  Gregory K. Webster, Ashley Elliott
  The use of UHPLC is getting a lot of attention these days for moving pharmaceutical and environmental chromatographic applications to improved capabilities in selectivity and detection. Yet, UHPLC has one fundamental flaw in the eyes of many lab managers – it requires new capital outlays to buy instrumentation capable of running at the required higher pressures (up to 15,000 psi).

• Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005–2010...

  Scott VW Sutton, Ph.D., Radhakrishna Tirumalai, Ph.D.
  This article is a comprehensive review of the published activities of the Microbiology and Sterility Assurance Expert Committee (MSA EC) of the United States Pharmacopeial Convention (USP) Council of Experts for the 2005–2010 revision cycle.

• Future Materials for Prefilled Syringe Components

  Patty H. Kiang, Ph.D.
  The growth of biologics is an important factor for the injectable drug delivery systems market. Prefilled syringes are gaining attention in drug delivery because of the value they offer in improving administration, patient compliance, increased safety, and dosing accuracy.

• Analytical Laboratory Efficiency Improvement in a Dynamic Pilot Plant Environment

  Douglas Scheesley, Leo Hsu, Ph.D., Josephine Vega
  The major challenge in drug development is to find a viable synthetic route while maintaining flexibility to address short timelines and limited resources, which are the common obstacles for every early phase project. For preclinical and early clinical work, making a few kilograms of an active pharmaceutical ingredient (API) is often the critical step. Under time and cost pressures, synthetic chemists do not have the luxury of trying to optimize synthetic routes.