March 2022

Bioreactor Characterization – Asset Library

Before we get into what’s the need for an Asset Library, let’s revisit the importance of Asset Characterization in technology transfer and Scale Up Process!Asset Characterization is an important step in determining the process performance capability of an equipment. Using Computational Tools / Software to characterize assets has reduced considerable time in planning future projects.Asset Characterization process …

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Asset Characterization with Interactive Webapps

Webapps are a great tool to create an interactive interface to visualizing the interaction of Process Parameters (PP), Process Metrics (PM) and Quality Attributes (QA). Let’s say we have a database of assets with it’s credential information and operating parameters. Next step is to access the information in an organized form, and an interactive webapp …

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What exactly is Feature Engineering ?

The goal is to turn data into information, and information into insight. – Carly Fiorina, Ex – C.E.O Helwett-Packard What exactly is Feature Engineering ? Feature Engineering (FE) involves leveraging techniques to analyze data, along with domain knowledge to crystallize information and actionable insights. When data is interpreted in a different way than conventional, it …

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Simple webapps for Fundamental Process Understanding

Ever wished for a way of easy dashboard reporting of advanced analysis across the organization with interactive abilities? Simple webapps are the perfect solution to that! They can be easily created in Python, executed with Voila (Jupyter environment native) and deployed over the air (OTA) with just a simple internet link. So what exactly is …

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Scale Up of Bioreactors – Have you ‘Understood’ your asset yet?

“I believe that thirty million of these animalcules together would not take up as much room, or be as big, as a coarse grain of sand.” –Antoine van Leeuwenhoek, 1632 to 1723 The advent of biotechnology marked one of the greatest revolutions in the history of mankind, undeniably the biggest one since the industrial revolution …

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Process Metrics: The Keystone of Process Understanding

Process metrics or PMs, are characteristics of a pharmaceutical process that are critical to ensuring product quality and process performance. They are characteristics of the processing ‘micro-environment’ for a given unit operations equipment or ‘process asset’. Generally speaking, maintaining these CPMs at the same (or nearly same) values across scales is a necessary condition for …

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Asset Characterization: Digital Nameplating of Assets

Asset characterization is an important step in determining the process performance capability of a given unit operations equipment. As we saw in an earlier post, it forms the backbone of process understanding and science-driven development/transfer. Lets recap things a bit here: asset characterization can be performed conveniently using computational/first-principles models. this results in a digital …

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Process Signatures: How can you stop worrying & start loving Scale Up

Process signatures capture the scale-independent relationships for a given unit operation or unit process. They represent scale-up or transfer rules that can be used to seamlessly move processes from one equipment to another, from site to another etc. Process signatures are based on the tenet that achieving process similarity is the same as achieving similarity …

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Fundamental Understanding of Pharma Process

Pharma processes are among the more complex processes in the chemical industry. Over the past decade or so, the traditional “quality-by-testing” approach of trial-and-error is being consciously replaced, partly or fully, by a more scientific approach across all aspects of pharmaceutical engineering – discovery, development and manufacturing. This “Quality by Design (QbD)” paradigm – which …

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