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Category Archives: Route Scouting

5 Common Challenges Scaling Up an API

Posted on September 3, 2017 by

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

6 Pharma API Regulatory Challenges to Watch

Posted on July 17, 2016 by

A couple of years ago, I published a post on 5 API Regulatory Challenges to Avoid, and it was interesting to look over the list and contemplate what updates I’d…

Posted in API synthesis, APIs, Big Data, FDA, genotoxic impurities, green chemistry, method development, Quality, regulatory, Route Design, Route Scouting, synthesis, Synthesis Route | Comments Off on 6 Pharma API Regulatory Challenges to Watch

Contract API Manufacturing Challenges: From Micro-batches to Multi-Tons

Posted on May 1, 2016 by

With technology racing onward, drugs are becoming more complex than ever before – along with their active ingredients and the processes that produce them. Different Challenges, Different Scales – The…

Posted in Contract Manufacturing, drugs, method development, Route Design, Route Scouting, scale-up | Comments Off on Contract API Manufacturing Challenges: From Micro-batches to Multi-Tons

Embracing Green Chemistry

Posted on December 20, 2015 by

There’s an article on Piramal’s Pharma Solutions division at PharmTech about how they are encouraging pharma companies to implement green chemistry earlier in the drug development cycle. Yes, we agree…

Posted in analytical science, API synthesis, APIs, atom economy, Benign-by-Design, Chemistry, CMC, Contract Manufacturing, corporate stewardship, EHS, energy conservation, energy effciency, green chemistry, method development, Neuland Labs, Route Design, Route Scouting, synthesis, Synthesis Route | Comments Off on Embracing Green Chemistry

Genotoxic Impurities – Increasing Vigilance, But Still Some Uncertainty

Posted on December 6, 2015 by

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

Green Chemistry and Benign by Design

Posted on September 6, 2015 by

7 ways to boost profits and reduce pharma synthesis waste At Neuland, we’re advocates of green chemistry. Not only is it better for the environment, but it’s also just logistically…

Posted in analytical science, API synthesis, APIs, atom economy, Benign-by-Design, Capabilities, Chemistry, CMC, Contract Manufacturing, EHS, energy conservation, energy effciency, green chemistry, ICH, Impurity profile, Quality, R&D, Route Design, Route Scouting, small molecule, synthesis, Synthesis Route, Uncategorized, zero liquid discharge | Comments Off on Green Chemistry and Benign by Design

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

Posted on June 1, 2015 by

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