What sort mindset do you need to help ensure adherence to cGMP standards?

When it comes to understanding what sort mindset is required in order to help implement and adhere to cGMP standards, here are a few things to consider: it is the baseline of all biomanufacturing workflows. Point blank. It’s the basics, it’s the “way of life” in a biomanufacturing facility, and it is (gratefully) not an …

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What does progression look like in the fight against racism? Where to start.

A quick note: Just because you’ve normalized my trauma, uncomfortability, and plight against racism doesn’t mean you get to use “soft language” to put yourself in a position of comfort WHENEVER my experiences, any general topic of racism, and the thought of anti-racist acts are in conversation. To the Caucasian individuals:You need to ask yourself, …

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An update on the George Floyd sparked DEI initiatives

The DEI space became a sector of popularity after George Floyd’s death. Like wild fire there was a deluge of individuals; who never focused on this type work prior to this event, now participating in what looked like a wave of positive change. Keep in mind that DEI initiatives were created to “address” Black issues …

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cGMP violations, who has time for that? If your goal is impeccable data integrity, you don’t.

To what extent would a cGMP violation damage your operation? Do you know? Every organization has a set of guidelines, rules and regulations they need to adhere to and these are usually industry specific. If you are in business, this is common knowledge, or should be. You may also realize that if you contravene these …

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Open vs Closed Systems in Pharmaceuticals – Things to Consider Regarding 21 CFR Part 11 Adherence

Photo by Tima Miroshnichenko If you've taken General Chemistry or Physics at any point, you are probably familiar with "systems" as referred to in thermodynamics. It is the study of energy and matter transfer that occurs in molecules or a collection or network of molecules. In Thermodynamics, an open system means both energy and matter …

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Batch to Continuous Manufacturing Processes

What are some of the decision-making tools that would allow you to move from batch processing to more continuous drug substance manufacturing? Over the last few years and especially after the emergence of COVID-19, interest in this topic has increased significantly. Companies are looking for ways to respond to needs from existing customers but also …

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Bread and Tissue Engineering have a lot in common

Did you know that the ancient art of bread making; artisan bread, is contributing to science in a big way? Specifically, studying the use of bread as a biomaterial scaffold is helping innovate tissue engineering methods. To be quick, instead of making the bread using the basic ingredients of flour, water, salt, and yeast like …

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