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Category Archives: Route Design

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

Unveiling Neuland’s Process Engineering Lab: Tightening our Focus on QbD

Neuland has recently welcomed the addition of a new, dedicated Process Engineering Lab to its R&D Center. The lab opened in March, and supports operations and safety studies via a…

Posted in Chemistry, CMC, Contract Manufacturing, drugs, method development, Neuland Labs, process chemistry, Process Engineering, QbD, Quality, Quality Agreement, R&D, Route Design, scale-up, synthesis | Comments Off on Unveiling Neuland’s Process Engineering Lab: Tightening our Focus on QbD

6 Pharma API Regulatory Challenges to Watch

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

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

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

Green Chemistry and Benign by Design

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

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

No Straight Line: Confronting API Scale-Up Challenges

In many of the blog posts we’ve written over the last few years, we’ve referenced the growing complexity of active pharmaceutical ingredients (APIs). It isn’t just mindless chatter intended to…

Posted in CMC, Contract Manufacturing, CRO/CMO, R&D, Route Design, scale-up | Comments Off on No Straight Line: Confronting API Scale-Up Challenges

Contract Drug Manufacturing R&D: from Route Scouting to Kilo Labs

Let’s face it – ‘cost-effective capabilities’ is a big reason why CROs and CMOs continue to be a highly-popular drug commercialization route of choice. Where else can you find ready-to-go…

Posted in analytical science, Chemistry, CMC, Contract Manufacturing, CRO/CMO, R&D, Route Design | Comments Off on Contract Drug Manufacturing R&D: from Route Scouting to Kilo Labs

The Benefits of Synthesis Scouting

The Right Route Can Deliver Fewer Steps, More Consistent Batches, Cleaner Processes…and Cost Savings With drug development and manufacturing processes becoming more complex, alternate synthetic route design is often a…

Posted in Chemistry, CMC, Contract Manufacturing, CRO/CMO, EHS, green chemistry, method development, R&D, Route Design, Synthesis Route | Comments Off on The Benefits of Synthesis Scouting