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Author Archives: Saharsh Davuluri

The Growing Impact of Rare Disease Drugs

AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals  joined by Merck’s acquisition of Acceleron for $11.5 billion and other deals, have made the Rare Disease space a destination for Big Pharma this…

Posted in drug discovery, drugs, FDA, Orphan drug | Tagged , | Comments Off on The Growing Impact of Rare Disease Drugs

Deuterated Drug Molecules: Perfecting the Gamechanger

Scientific breakthroughs in the pharmaceutical industry can happen overnight, but it still takes time to perfect a discovery’s applications. Deuterium-labeled active pharmaceutical ingredients (APIs) are one specific advancement that has…

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Pharma 2020-2021: Much More Than Just COVID

Set aside ‘Everything-COVID,’ and to many outsiders the past 20 months can appear as though the pharmaceutical industry took a sabbatical. Not true, of course…but everything else that occurred in…

Posted in Chemistry, COVID19, drug discovery, drugs, Industry news, R&D, supply chain | Comments Off on Pharma 2020-2021: Much More Than Just COVID

Where Does Pharmaceutical Process Control Start?

The idea of gaining – and maintaining – adequate process control during drug synthesis isn’t new. It underscores the entire point of approaches such as Quality by Design (QbD), and…

Posted in API synthesis, APIs, Chemistry, CMC, process chemistry, QbD, Quality, Route Design, Route Scouting | Tagged , , , | Comments Off on Where Does Pharmaceutical Process Control Start?

What to Expect during Pharma Contract Manufacturing Project Onboarding

When your company decides to work with a CMO or CDMO on a drug API manufacturing project, the depth of the onboarding process dictates the success of the project. Onboarding…

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What Lessons Has Pharma Learned From COVID?

There’s an eye-popping amount of good news for pharma floating around out there. One report claims a ‘Golden decade of unbelievable innovation’ lies ahead. Others point to COVID19 as the…

Posted in Contract Manufacturing, COVID19, drug discovery, drugs, R&D, regulatory | Comments Off on What Lessons Has Pharma Learned From COVID?

What are Some of the Key Trends in Analytical R&D Labs?

Five years ago this month, we published a post on emerging analytical R&D trends, discussing key techniques such as Multi-Dimensional Liquid Chromatography, Hyphenated Mass Spectrometric Techniques, Error Analysis, Semi-Micro Methacrylate…

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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…

Posted in APIs, Capabilities, Chemistry, Contract Manufacturing, process chemistry | Tagged , , , , | Comments Off on What Does it Take to Become a Specialist in Late-Phase CMS?

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