Formulating and manufacturing drugs for preclinical testing is an early—and necessary—step towards pushing your molecule through to human clinical trials. At the preclinical stage, the goal is to maximize exposure for safety testing, formulating the limits of solubility and maximum volume. To optimize the formulation for preclinical testing, it’s important to consider the following for informed decision-making regarding feasibility, scale-up, and the future success of your program: route of administration, excipients selection, stability testing, scale-up plans and options, and contingency plans.

Issue 38 of The Altascientist explores the key considerations for successful formulation development and manufacture for safety assessment, alongside examining the strategies Altasciences employs to support you in planning your program. 
Preclinical manufacturing involves various sub-processes, all of which are critical in overall drug development. And in this issue, you will discover these sub-processes in detail, including: