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Category Archives: APIs

How to Ensure Effective Technology Transfer to CDMOs

Technology transfer from pharmaceutical companies to contract development and manufacturing organizations (CDMOs), is critical to successful drug development. When you consider the skills, knowledge, intellectual property, technologies, and manufacturing methodologies being…

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Why Agility Matters When Choosing an API Contract Manufacturing Partner

A company’s ability to pivot and adapt — its agility — is more than just an asset. In today’s dynamic contract manufacturing landscape, it’s a necessity. Agility allows a CDMO…

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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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API Particle Size Part I: Overcoming the Challenges to Ensure Quality Pharmaceutical Products

API particle size is a key consideration in manufacturing quality pharmaceutical products, however, particle size is also notoriously difficult to control during manufacturing. Despite the difficulty, it’s essential to get…

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Scaling-up Active Pharmaceutical Ingredient (API) Chemistry for Phase 3 Clinical Trials and Bulk Manufacturing for a Potentially Novel Treatment for Schizophrenia

Selecting the right pharmaceutical contract manufacturing partner for Phase 3 clinical and commercial supply is challenging. There are several critical qualifiers you need to consider: Do they have the expertise…

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R&D Expert Talks Pharma API Scale Optimization

To be successful, pharmaceutical innovators and biotech organizations need to optimize production and achieve higher yields of their active pharmaceutical ingredients to make products more cost-effective. To realize these results,…

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The Crucial Role of Crystallization in Drug Substances Development

The development of drug substances heavily depends on a thorough and precise understanding of its different processes. One of these critical steps is crystallization, which has a significant impact on…

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What Pharmacological Advantages Can Deuterated APIs Deliver?

There have been significant changes in the pharmaceutical industry over the past few years, and some of them have led to significant breakthroughs. One example is the growth of deuterated…

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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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Putting Customers First: Customer Centricity in Pharma API Manufacturing

Customer centricity is central to every organization and an important strategic priority for B2B companies. While there are many definitions of customer centricity, the ultimate objective of a customer-centric organization…

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