Archive for the Development Category

Dealing with contract research organizations (CROs) can be a nightmare for some drug developers. You may be a start-up pharmaceutical company with one molecule and you now need to hand over your baby to a cold and unfamiliar group of people who haven’t been nurturing this project for years. Maybe you are in academia and this is your first big chance to spin off your own company and you need a partner to help you with development. Whoever you are and whatever your situation; it can be daunting to select and partner with a CRO. Here are five key factors to keep in mind when trying to troubleshoot drug development delays by selecting the right CRO:

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:

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: