Newsletter | July 18, 2025

07.18.25 -- A Look At Elsa, The FDA's New AI Digital Assistant

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INDUSTRY INSIGHTS

Measuring Thermodynamic Parameters In The Drug Development Process

Join Dr. Ladbury to explore how thermodynamic data can enhance our understanding of protein-ligand interactions and how it is crucial for optimizing drug efficacy and safety in pharmaceutical development.

Strengthen Pharmaceutical Supply Chains With A U.S.-Based CDMO

While certain ingredients require sourcing abroad, partnering with a U.S.-based company that owns its manufacturing assets allows for direct oversight of product quality and supply reliability.

What Is DMPK, And Why Does It Matter In Drug Development?

By leveraging advanced DMPK software solutions, you can streamline your workflows and make informed decisions with confidence.

What Drug Manufacturers Should Know About Operational Readiness

Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.

Common Tablet Defects And The Importance Of Blending

Learn to minimize tablet defects like picking, sticking, and capping, as well as uncover common issues and the critical role of blending in achieving quality tablets.

N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS

A company wanted to increase productivity 2-3 times in their fed-batch facility and also reduce their current cost of goods. With one small change in the upstream seed train, the customer met their goals.

Utilizing Fed-Batch Intensification To Increase Titer In Manufacturing

Find out how the advanced principles of process intensification can be applied to process and equipment design, increasing facility throughput, and ultimately offering a wide range of benefits to customers.

Effectively Enabling Rare Diseases To Reach Patients

To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

Systems And Software For Compliant Serialization And Aggregation

This track and trace workflow illustrates the many moving parts involved in production and where two software solutions can be integrated into your systems and processes to maximize efficiency.

How To Secure A Sustainable Supply Of API

How can pharma companies secure the supply of vital APIs and intermediates and maintain consistent manufacturing costs? These steps minimize supply chain insecurity in a rapidly changing market.

Building A Connected Quality And Manufacturing Ecosystem In Life Sciences

Examine the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.

The Evolution Of A CDMO

Transitioning from a product-based to a service-based organization helped a leading CDMO commit to client-centricity and operational excellence and meet the evolving needs of the pharmaceutical industry.

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FEATURED EDITORIAL

A Look At Elsa, The FDA's New AI Digital Assistant

The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

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Developing A mAb For A Small Biotech Developing Precision Medicines

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