Articles in this Issue

• Extractable and Leachable Implications on Biological Products in Prefilled Syringes

  Yasser Nashed- Samuel, Dengfeng Liu, Kiyoshi Fujimori, Lourdes Perez, Hans Lee, Ph.D.
  Prefilled glass syringes (PFS) are increasingly becoming a container of choice for storing and administering therapeutic protein products to patients [1].

• Amorphous Solid Dispersions as Enabling Formulations for Discovery and Early Development

  Brian E. Padden, Jonathan M. Miller, Timothy Robbins, Philip D. Zocharski, Leena Prasad, Julie K. Spence, Justin LaFountaine
  It is frequently reported that the percentage of drug candidates that are limited by poor solubility is increasing [1,2]. These poorly soluble compounds typically require enabling formulations, and this trend creates challenges for teams in discovery and development who must drive in-vivo exposures high for animal toxicology studies and deliver robust dosage forms for clinical evaluation. Many enabling technologies are available for the formulator to consider, including lipids, cosolvents, surfactants, nanoparticles, cyclodextrin complexes, amorphous solid dispersions, and others.

• Transfer, Implementation and Late Stage Development of an End-To-End Single-Use Process for...

  Brian Mullan, Ph.D., Kristi Huntington, Aidan Collins, Marie Murphy, Ph.D.
  Disposable manufacturing platforms are becoming increasingly popular for therapeutic monoclonal antibody (MAb) manufacture, whether as fully disposable platforms or for incorporating single use solutions in to largely fixed (i.e., stainless steel-based, re-usable) manufacturing platforms.

• Case Studies of Microbial Contamination in Biologic Product Manufacturing

  Kalavati Suvarna, Ph.D., Anastasia Lolas, Patricia Hughes, Ph.D, Richard L Friedman
  The manufacture of biologic products is a complex process and requires the use of living cells. These processes and products are prone to contamination by adventitious agents such as bacteria, fungi and viruses. Microbial contaminations have a huge impact on biologic product manufacture as they introduce product variability and can cause loss of potency due to degradation or modification of product by microbial enzymes, changes in impurity profiles, and an increase in the levels of bacterial endotoxins.

• Limitations of Some Commonly Described Practices in Drug Dissolution Testing and Suggestions...

  Saeed A. Qureshi
  Dissolution tests are employed to establish the quality of drug products, mostly tablets and capsules, based on in vitro drug release characteristics of these products. In reality, a dissolution test may be considered as a simple extraction step in a vessel with a stirrer.

• Physical Characterization of Nano Particulates Used in the Pharmaceutical Industry

  Ronald Iacocca, Ph.D.
  Nano particulates or nano-scaled pharmaceutical products have received great interest for the past two decades. Reduction in size to the nano scale can offer unique therapeutic advantages, such as the ability of particles to pass through cell membranes, thereby targeting specific cells.

• Approaches to Quantification of Amorphous Content in Crystalline Drug Substance by Powder X-ray...

  Peter Varlashkin, Ph.D
  Typically, the desired solid state for active pharmaceutical ingredients (drug substance) is crystalline. Amorphous content within the crystalline drug substance may have a deleterious impact on the drug product such as reduced chemical and physical stability.

• The Adaptable Laboratory: A Holistic Informatics Architecture

  James M. Roberts, Ph.D., Mark F. Bean, Ph.D., Chris Bizon, Ph.D., John C. Hollerton, William K. Young, Ph.D.
  In a previous paper, we advocated a laboratory informatics solution comprised of simple, modular applications rather than currently available “big box” solutions; several examples of efficient and novel capabilities were provided [1].