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Category Archives: process chemistry

What Does it Take to Become a Specialist in Late-Phase CMS?

When a drug transitions from early-stage development to late-stage development, the drugmaker has some big decisions to make. Chief among them: Who are they going to work with to move…

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How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

Stating the obvious here, but drug development is a protracted, expensive and risky process. From the lab bench to pharmacy shelves, bringing a new drug to market often stretches 10+…

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How to Create Sustainable Drug Lifecycles with Alternate Route Scouting

Demands on a drug’s synthetic processes naturally evolve during its lifecycle. Scouting alternative methods for synthesizing active pharmaceutical ingredients (APIs) early in process development — before they are needed by changing…

Posted in API synthesis, APIs, atom economy, Chemistry, Effluent, EHS, energy conservation, energy effciency, green chemistry, process chemistry, Route Design, Route Scouting, synthesis, Synthesis Route | Tagged , | Comments Off on How to Create Sustainable Drug Lifecycles with Alternate Route Scouting

API Production: Building a Process Safety Culture

Working in the pharmaceutical manufacturing industry may bring many rewards, but it also has an element of risk. We often work alongside hazardous chemicals, in both labs and manufacturing spaces….

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Looking for an API Supplier? 5 Things to Consider (Updated)

Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, drugs, FDA, Neuland Labs, process chemistry, Process Engineering, Project Management, Quality, R&D, regulatory, supply chain, synthesis | Tagged , , | Comments Off on Looking for an API Supplier? 5 Things to Consider (Updated)

Process Validation: Maintaining Quality Consistency

The basic principle of pharmaceutical quality assurance is that a drug should be safe and effective for its intended use – and process validation plays a pivotal role in ensuring…

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Valsartan Contamination: A Follow-Up

Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…

Posted in APIs, CMC, drugs, FDA, genotoxic impurities, Impurity profile, process chemistry, QA/QC, regulatory | Tagged , , , , , , | Comments Off on Valsartan Contamination: A Follow-Up

On SABAM, Cyanide and Safety

Levetiracetam, an epilepsy medication used for partial onset, myoclonic or tonic-clonic seizures, was first approved for medical use in the United States in 1999. As a drug, it boasts excellent…

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Unique API Particle Size Projects On the Rise

Why is there a growing preoccupation with particle size? It’s because particle size can alter the efficacy (e.g., bioavailability) and safety profile (e.g., toxicity) of a compound. Complex particle sizing…

Posted in APIs, Chemistry, CMC, drugs, Impurity profile, micronization, Neuland Labs, particle size, process chemistry, Process Engineering, QbD | Comments Off on Unique API Particle Size Projects On the Rise

How the Valsartan Contamination Happened: Its Context & Implications

Last year’s valsartan contamination and recall brought some surprising chemical synthesis issues to light in the pharma industry. While the reactions used in generic valsartan production are known to be…

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