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Category Archives: API synthesis

API Particle Size Part 2: New & Emerging Technologies Impacting Particle Size

Welcome to Part 2 of our series on managing API particle size. (You can find Part 1 here.) Today we’re talking about some of the new and emerging technologies that…

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Advancing a Cholesterol Lowering Drug at the Height of the Pandemic

How Neuland Expanded Esperion’s Bempedoic Acid Amid Pandemic Lockdowns and Supply Chain Interruptions Just as COVID was making itself known in February 2020, the FDA was approving Esperion Therapeutics’ new…

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3 Key Elements of a Successful Hydrogenation Scale-Up

Pharmaceutical process chemistry has come a long way since wholesale merchants began the commercial marketing of drugs in the 19th century. In fact, process chemistry has driven many of the…

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Regulatory Starting Materials: How to Source, Analyze and Validate Suppliers (Part II)

In Part I of this two-part series, we explored sourcing and supplier management of Regulatory Starting Materials (RSMs), and how effective designation and justification of RSMs begins with supplier market…

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Regulatory Starting Materials: How to Source, Analyze and Validate Suppliers (Part I)

Supply chain management is an essential chapter in the pharmaceutical manufacturing handbook. Managing regulatory starting materials (RSMs) seeks to maximize commercialization and sustainability while meeting and/or exceeding regulatory requirements. Drugmakers…

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Green Chemistry by Design (GCbD): The Earlier, The Better for Pharmaceutical APIs

There’s a growing consensus in the pharmaceutical industry that drug makers should embrace green chemistry. The last decade of pharma manufacturing has seen green chemistry practices shift from aspirational stewardship…

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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…

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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…

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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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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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