Navigation For Mobile

Author Archives: Saharsh Davuluri

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…

Posted in Contract Manufacturing, outsourcing, Project Management, Quality | Tagged | Comments Off on What to Expect during Pharma Contract Manufacturing Project Onboarding

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…

Posted in analytical science, drugs | Tagged , , , | Comments Off on What are Some of the Key Trends in Analytical R&D Labs?

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

Small Pharma Steps Up

Here’s some good news, courtesy of DCAT Value Chain Insights: “Smaller bio/pharmaceutical companies are accounting for an increasingly larger portion of new products as measured by recent new molecular entity…

Posted in drug discovery, drugs, FDA | Tagged , , , , | Comments Off on Small Pharma Steps Up

Why You Need to Have the ‘Supply Chain’ Conversation with Your Pharma Suppliers

Supply chain security has been the subject of numerous posts on this blog in the past. It is important to note, however, that the pandemic hasn’t widely impacted global supply…

Posted in APIs, CMC, Contract Manufacturing, COVID19, supply chain | Tagged , , , | Comments Off on Why You Need to Have the ‘Supply Chain’ Conversation with Your Pharma Suppliers

Blockbuster Drugs Hang On: Is a Post-Blockbuster World in Sight Yet?

“Blockbuster” drugs — typically defined as those that generate annual sales of $1 billion or more — have been the lifeblood of Big Pharma company revenues since Smith, Kline and French’s…

Posted in blockbuster, drugs | Tagged , , , | Comments Off on Blockbuster Drugs Hang On: Is a Post-Blockbuster World in Sight Yet?

Atmanirbhar Bharat and PLI: A Future From the Past

It is difficult to discuss India’s ‘Make in India’ plan without reference to China, and any discussion of India-China relations ultimately leads to a political – rather than economic or…

Posted in India, outsourcing, supply chain | Tagged , , , , , | Comments Off on Atmanirbhar Bharat and PLI: A Future From the Past