ISSUE NO. 38 — Achieving 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
Also included is a case study about how Altasciences helped a client get their new API through the preclinical development phase with a robust formulation at the maximum potency.
Three Platforms Used to Monitor Cytokines and the Complement System
Monitoring both cytokines and complement factors in drug development has become increasingly important, as the movement toward personalized treatments for cancers and genetic diseases has spurred research and development into biologics, vaccines, and small molecules that can have unintended consequences due to their immunomodulatory effects.
First-in-Human Solution for Small and Large Molecules
Clinical Pathology Reference Data for the Philippine Cynomolgus Monkey for Preclinical Toxicology Studies
Comparison of Safety Pharmacology End Points Used on Toxicology Studies Across Differing Cynomolgus Monkey Origins
Cross-Comparison of Biomarker Assay Performance in Nonhuman Primates
Cross-Comparison of Immunophenotyping Assay Performance in Nonhuman Primates
Development of a Canine Prostatectomy Model
Development of a Novel Early Intervention Stabilization for Abdominal Aortic Aneurysms