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Blog

The Top 2 Elements of FAT Planning

By Keith Weseli, December 13, 2018

 

Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the overall verification process.

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Are paper batch records slowing you down?

By Michael Morrison, November 13, 2018

How are batches managed?

 

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AAV Vector Production

By Robert Ossig, September 4, 2018

Overview

Until about 2016, the majority of vectors used in gene therapy were Adenovirus and Retrovirus vectors.  In recent years, a change toward Lentivirus and Adeno-associated virus (AAV) vectors has occurred.  This is reflected when looking at the numbers in current clinical trials underway in the gene therapy field.

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Maximizing the Impact of Factory Acceptance Testing

By Keith Weseli, September 19, 2017

 

Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the overall verification process.

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How to Understand ASTM E2500