Industrial Perspectives on Continuous Drug Product Manufacturing – An IQ Consortium Survey

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Aditya Vanarase, Brendon Ricart, Ahmad Almaya, Lawrence DeBelder, Wyatt J. Roth

 

Introduction

Solid oral dosage forms are generally considered to be the preferred administration vehicle for medicinal products by both patients and the pharmaceutical industry because they are noninvasive, easy to administer, and cost effective to produce. Of all of the different solid oral dosage forms available, tablets and capsules are the most common. Historically, tablets and capsules have been manufactured using batch unit operations, i.e., those “in which all materials are sequentially loaded into the unit operation, then transformed [for example, blended, granulated, etc.], and finally unloaded.”1 However, the pharmaceutical industry is currently in the midst of a paradigm shift away from batch manufacturing and toward continuous manufacturing (CM). As part of this transition, a drug product continuous manufacturing working group (CMWG) was established through the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium).2 One of the main goals for the CMWG is to provide a precompetitive and technically focused venue for members to discuss various topics related to CM.

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August 2020