Articles in this Issue

• Qualification Strategies for Blinded Comparators: One Company’s Perspective

  Karen Back-Moore
  While GMP for clinical supply manufacture is written vaguely and “interpretable,” at least there are long established guidelines, both formal (e.g., Code of Federal Regulations, International Conference on Harmonization) and informal (e.g., Gold Sheet, Guidelines for Industry).

• Predicting Manufacturability During Biopharmaceutical Discovery

  Susan Dana Jones, Ph.D.
  Today’s biopharmaceutical products often consist of complex engineered synthetic protein sequences or fusions of sequences that are not normally found together in nature.

• Regulatory Strategy for Long-Term Stability Conditions to Support Submission in Zone IV Countries

  This paper provides a recommendation for selection of long-term stability conditions for submission of room temperature storage drug products in Zone IV countries in the face of a confusing mixture of expectations from international regulatory bodies.

• A Rental or Leasing Program for Small Reusable Package Shippers for Temperature – Controlled...

  Rafik H. Bishara, Ph.D.
  Substantial sums of budgets and resources are spent annually to design packages (containers) to ship temperature-controlled products.

• Effective Formulation Development Strategies for Poorly Soluble Active Pharmaceutical Ingredients...

  David P. Elder, Ph.D.
  One of the least desired outcomes of utilizing combinatorial and high throughput chemistry has been a marked increase in poorly soluble drug candidates.

• An Interview with Stephen A. Cutler, PhD, MBA ,Senior Vice President and Chief Operating Officer,...

  Stephen A. Cutler, PhD, MBA
  The elements are in place for a perfect storm to send clinical development costs skyrocketing even higher.