Inside The Altascientist: How to Achieve Optimal Preclinical Formulation and Drug Product Manufacture
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:
- formulation development
- manufacturing process development
- scale-up
- process validation
- analytical method development and validation
- quality assurance and control
- stability studies
- regulatory compliance
- risk management
Listen or read Issue 38 of The Altascientist on altasciences.com, or wherever you listen to podcasts.
WHAT IS THE ALTASCIENTIST?
The Altascientist is a scientific journal written by the scientific and research experts at Altasciences. In each issue, they share their decades of knowledge to help sponsors along their early-phase drug development journeys, as well as explore the latest challenges and innovations in the industry.
Explore the full collection of The Altascientist in our Resource Center, or listen to each issue in our audiobook library.
