Analysis Paralysis: Navigating Early-Phase Analytical Validation

Source: Singota Solutions By Dustin Lafferty, Singota Solutions Significant confusion persists across the pharmaceutical/biopharmaceutical industry relevant to early-phase analytical development and validation. While several guidance documents serve as a de facto standard, distinguishing method validation requirements from suggestions, when and how to apply those guidelines often is not a straightforward task.…

Lyophilization: An Important Formulation Tool

Because of the expense and risks in evaluating new drug entities, minimizing the parenteral formulation process/time is critical to initiating clinical studies. Companies have initiated clinical studies with frozen solution for this reason. However, this creates other problems in processing and distribution. A more feasible approach to short circuit the formulation process is lyophilization (freeze drying). Here’s why:

5 Elements of a Successful Analytical Method Transfer

No matter where your product is in the pharmaceutical pipeline, from early formulation development to commercial production, analytical procedures will be used to ensure the identity, quality, purity and potency of the drug substance or product. As a product moves from research and development to manufacturing, it may be necessary to order an analytical method transfer of your established (validated) procedure from one laboratory to another to achieve product realization. Here are 5 elements to ensure success: