Tag Archive | "Novartis"

Control, Innovation and the Consumer: Keys to a Different Drug Industry


By Ali Afnan, PhD, Principal, Step Change Pharma, Inc.

Over the years, pharma’s key objective has changed very little: getting active pharmaceutical ingredient to the patient. Although we no longer dose extracts of willow tree bark, the practice of blending API with excipients to add bulk or facilitate flow dates back to the Romans. The Remington tablet press or gelatin capsules of 1875 remain virtually unchanged today. Regulations haven’t changed that much either, in the fifty years since most of them were drafted.

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Case Studies: Multivariate Analysis at Novartis


The European Pharmaceutical Review recently published an article from Novartis on how it is using PAT tools and multivariate data analysis (MVDA) for statistical process control. The article by Marianna Machin, Lorenz Liesum and Antonio Peinado features background of Novartis’ PAT program, and two case studies, one each from the pharma and biopharma realms:

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Snippets from AIChE: Navigating QbD’s Shades of Gray


Last Wednesday at AIChE 2011 in Minneapolis, speakers from FDA and industry joined in a Round Table discussion on Quality by Design regulatory filings. What follows are some snippets from the open forum. Among the questions raised: Do we really need to distinguish between a QbD and non-QbD filing? How do we get upper management on board for QbD? How do chemical engineers get regulatory professionals believing in a QbD approach?

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2010′s Top Ten: Reader Favorites from a Memorable Year


The web works in mysterious ways, and sometimes it’s hard to know why certain articles or pieces of content go “viral” and others not. Regardless, as we get ready to ring in a new year, let’s take a look back at PharmaQbD’s most popular posts from 2010, based upon the number of page views. Thank you to all contributors who have made the discussion on our site lively and purposeful, and readers who have stopped in for a visit.

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With Continuous Operations, Can Drug Manufacturing Become a Rock Star?


By Paul Thomas, Senior Editor

Note: This is the fourth of four posts related to a continuous manufacturing symposium held at AAPS 201o last week.

At AAPS 2010 in New Orleans, James Evans, Associate Director of the Novartis-MIT Center for Continuous Manufacturing, presented a blue-sky vision of what integrated continuous manufacturing in pharma can look like, and suggested that the future is not as far off as we might think.

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The Paperless Validation Life Cycle: A Working Model from Novartis


By Paul Thomas, Senior Editor

At DIA 2010 in Washington, DC, Novartis Consumer Health process development manager Jim McElroy presented a case study on his facility’s move to a paperless cleaning validation environment.

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