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Category Archives: critical reaction parameters

QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

In recent posts on the topic of Quality by Design and drug manufacturing, we referenced (here, here and here) the importance of being able to reduce unanticipated challenges by developing…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CQA, critical reaction parameters, Design of Experiment, FDA, Impurity profile, Neuland Labs, process chemistry, QbD, Quality | Comments Off on QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

5 Common Challenges Scaling Up an API

While linear drug scale-up sounds great on paper, the reality is usually much different. In fact, scaling up an API can be challenging even under the best circumstances. In fact,…

Posted in APIs, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, method development, Neuland Labs, particle size, Route Design, Route Scouting, scale-up, synthesis | Comments Off on 5 Common Challenges Scaling Up an API

Genotoxic Impurities – Increasing Vigilance, But Still Some Uncertainty

A genotoxic impurity (GTI) is a chemical substance that can directly or indirectly damage DNA or chromosomes and induce genetic mutations. Fifteen years ago, there were no specific guidelines for…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, critical reaction parameters, genotoxic impurities, QA/QC, Route Scouting, Uncategorized | Comments Off on Genotoxic Impurities – Increasing Vigilance, But Still Some Uncertainty

Process Chemistry Goes Beyond Scale-Up

It’s a common misconception that process chemistry refers strictly to process scale-up. While it’s true that process chemistry is a crucial component of optimizing the scale up of an active…

Posted in Contract Manufacturing, critical reaction parameters, process chemistry, Uncategorized | Comments Off on Process Chemistry Goes Beyond Scale-Up

6 Properties of API Synthesis that Affect Yield, Delivery Date & Purity

I’ve mentioned the importance of route scouting in the past. Now I’d like to share some of the properties of API synthesis that can affect the yield, purity, and delivery date…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, method development, Route Design, Route Scouting, synthesis, Synthesis Route | Comments Off on 6 Properties of API Synthesis that Affect Yield, Delivery Date & Purity

You Can’t Keep a Good Drug Down

Reducing Mutagens, Carcinogens & Other Genotoxins to Improve Safety Profiles There are a number of process modifications API manufacturers can make to improve safety profiles, reduce production costs, improve capacity…

Posted in analytical science, APIs, Capabilities, Chemistry, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, drugs, EHS, genotoxic impurities, green chemistry, method development, Neuland Labs, QA/QC, QbD, R&D, regulatory, Route Design, scale-up, Synthesis Route, zero liquid discharge | Comments Off on You Can’t Keep a Good Drug Down

APIs & Chemistry: The Importance of Understanding Critical Reaction Parameters

Active Pharmaceutical Ingredients (APIs, or – in layman’s terms – the ingredients that makes drugs work) have grown increasingly complex. Today’s equivalent of boiling tree bark into a tincture typically…

Posted in analytical science, Capabilities, Chemistry, critical reaction parameters, drugs, genotoxic impurities, method development, QA/QC, R&D, scale-up | Comments Off on APIs & Chemistry: The Importance of Understanding Critical Reaction Parameters