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Category Archives: 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+…

Posted in APIs, Capabilities, Chemistry, CMC, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, scale-up | Tagged , , , , | Comments Off on How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

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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Earth Day 2021: Reinventing Business As Usual

April 22 is Earth Day and this year’s theme is Restore our Earth. On their website, Earthday.org states “When life around the globe returns to normal, our world cannot return…

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Overcoming the Challenges of API Complexity

Pharmaceutical drug molecules are becoming increasingly complex, posing challenges in formulation development and manufacturing. This is particularly true of small molecule drug APIs and peptides, both of which have a…

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Weighing the Potential for APIs and Finished Dosage Forms in Emerging Markets

New markets for drug manufacturers are emerging worldwide in regions that have typically purchased and imported drugs in finished dosage forms. While this shift has been underway for a few…

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Pharma Trends for 2021

After 2020, trying to predict anything at all seems a bit reckless. Most of us are still trying to wrap our heads around last year — and hoping this year…

Posted in APIs, blockbuster, CDMO, Chemistry, Contract Manufacturing, COVID19, CRO/CMO, outsourcing, supply chain | Tagged , , , , | Comments Off on Pharma Trends for 2021

Update on Regulatory Guidance for Facility Inspections

During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…

Posted in APIs, audit, Chemistry, CMC, COVID19, CRO/CMO, FDA, Industry news, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , | Comments Off on Update on Regulatory Guidance for Facility Inspections

The Impact of Impurities on the Pharmaceutical Industry

A significant paradigm shift is underway in the regulatory environment for impurities in pharmaceutical products. Recent incidents involving genotoxic impurities (GTIs) are driving tighter restrictions and guidelines, as well as…

Posted in API synthesis, APIs, Chemistry, drugs, genotoxic impurities, Impurity profile, QA/QC, Quality, Route Design, Route Scouting, synthesis, Synthesis Route, Valsartan | Comments Off on The Impact of Impurities on the Pharmaceutical Industry