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European Biopharmaceutical Review

Quality By Design: Defining Your Preclinical Package

John Avellanet at Cerulean Associates LLC demonstrates the advantages of using quality by design to define preclinical package

Shareholders and large investors alike are increasingly scrutinising a company’s biopharmaceutical pipeline through the critical lens of today’s reality; to bring a new biopharmaceutical product to market requires 10-15 years, costs an average of $1.2 billion and has a paltry success rate of one out of 250 (1). For investors, shareholders and executives alike, the crucial question – how to speed time-tomarket, lower costs and improve the success rate – remains unanswered. And yet, over the past few years, regulators have steadily put forth one answer: ‘quality by design.’ Given my experiences over the past 15 years in product development, commercialisation and regulatory compliance programmes, quality by design can cut development time by at least one to three years, save at least $102-290 million, and ease regulatory approval with one caveat: if tackled in an overzealous, process-validation manner, similar to the early misinterpretations and costly attempts at 21 CFR Part 11 compliance, adoption of quality by design will stumble, proving more promise than fact.

In light of that risk, this article presents a real-world quality by design strategy for biopharmaceuticals looking to develop a faster, less expensive and more user-friendly preclinical package for a new product. The article is based on published FDA insights, discussions with FDA officials and other scientific experts, plus recent client experiences.

QUALITY BY DESIGN

Quality by design is part of the FDA’s good manufacturing practices for the 21st century. However, before the FDA’s adoption, quality by design had been in widespread use throughout the consumer product and software development marketplaces for the past 25 years. Toyota is famous for its use of quality by design techniques to incorporate predefined product aspects (such as consumer preferences) as early as possible in the product design phase. Such predefined product aspects establish a product vision which serves as a reference to arbitrate conflicting constraints, limit late stage changes, increase product quality and lower overall development and manufacturing costs.


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John Avellanet is a successful business executive and independent compliance advisor. His consulting firm, Cerulean Associates LLC, works with executives who want to improve their regulatory compliance, intellectual property security and information integrity. He is a repeat guest on internationally-syndicated business radio shows, a frequent speaker at universities, businesses and non-profit trade associations, and co-author of the forthcoming book, Advanced Topics in Biotechnology Business Development.
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