Considerations for Successful Scale-Up To Tox Batches And Phase-Api (Bulk Drugsubstance)

Krishna Sarma Pathy

doi:10.32474/lojms.2018.01.000112

Abstract

Considerations for Successful Scale-Up To Tox Batches And Phase-Api (Bulk Drugsubstance)

Highlights

Since phase 1 studies are generally first in human studies, they are the initial baseline for establishing the safety of the product in people
Because changes to product quality could affect patient safety, this paper focused on establishing a controlled manufacturing process and a set of analytical assays to detect any changes to the product which could potentially impact patient safety
If the points in the paper are followed, the elements for a strong IND bulk drug substance development package and robust manufacturing process should be in place

Summary

Introduction

Since phase 1 studies are generally first in human studies, they are the initial baseline for establishing the safety of the product in people. Most of the SELECT criteria can usually be satisfied when preparing the first few kilograms of the API or New Chemical entity (NCE) in bulk In these early clinical trial stages, the most frequent issue encountered involves patient safety. The most important factors in developing “right-first-time” processes a) Chemical yield b) Cycle time c) Number of chemical steps and convergence d) Use of higher molecular weight protecting group and reagents e) Number of energy-consuming operations. Implementing this approach is key to reducing API development time as complexity grows and budgets shrink.

LOJ Med Sci

Challenging the Parameters

Gaining Regulatory Approval