Newsletter | October 16, 2025

10.16.25 -- 10 Ways To Strengthen U.S. API: Part I

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Webinar: AI In Action: Driving Operational Excellence in Life Sciences

Discover how CAI and phData are redefining compliance and operational readiness in life sciences. Join our webinar to see how advanced AI solutions slash manual effort, expedite facility readiness, and improve accuracy in regulated environments. Learn from real-world case studies where thousands of labor hours were reduced to hours—freeing teams to focus on higher-value activities. Click here to learn more.

INDUSTRY INSIGHTS

Your Environmental Monitoring Can't Be Your Only Line Of Defense

Environmental monitoring (EM) is essential, but it’s only part of the picture. Discover why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.

Testing And Selecting A Detergent Cleaning System

Testing and selecting an aqueous cleaning system involves a seven-step process. In this chapter of The Aqueous Cleaning Handbook, we walk through those steps to help you optimize your cleaning process.

Mastering Ethylene Oxide Sterilization: Your Comprehensive Field Guide

Whether you're refining existing protocols or developing new ones, this guide serves as a valuable resource for ensuring safe, effective, and compliant sterilization outcomes.

FROM THE EDITOR

10 Ways To Strengthen U.S. API: Part I

Bringing the API supply chain closer to home not only strengthens the supply chain for U.S. drug makers, but it also strengthens the U.S. reserve of critical medicines.

INDUSTRY INSIGHTS CONTINUED

The Case For Pre-Owned Equipment In Drug Manufacturing

Discover how used equipment can deliver faster ROI by eliminating long lead times and reducing capital outlay, allowing for quicker production and revenue generation.

Friendshoring: A Strategic Shift In Pharma Supply Chains

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

Considerations For Pre-Filled Syringes For 503(b) Compounding Facilities

Industry experts weigh in on how to help 503(b) compounding facilities bring acute care drugs to market more quickly, provide a safer drug administration process, and minimize health care and hospital costs.

Safely Navigating The Transition From MDD To MDR

If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

Human Skin Explant Model For The Investigation Of Topical Therapeutics

Learn more about an ex vivo cultured human skin explant model in which pathological tissue integrity, barrier function, and metabolic stability have been characterized over time.

Managing Endotoxins - Detect, Prevent, Remove

Explore the risks of endotoxin contamination in drug manufacturing and discover sustainable, animal-free detection methods to ensure pharmaceutical safety and regulatory compliance.

Empowering Healthcare With Innovative Medical Polyurethanes

Gain insights into how medical polyurethanes are enhancing medical devices, improving patient outcomes, and driving innovation in the healthcare industry.

Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

Expanding Opportunities For Inhaled Drug Delivery

Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.

Scaling Up A Revolutionary Amorphous Solid Dispersion Platform

Process parameter and quality attribute relationships, including those for typical pre- and post-ASD unit operations, will be explored in the context of real-world examples.

Engineering Approaches To Respiratory Drug Delivery

Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.

Simplifying Recipe Creation In The Life Sciences

Discover how an innovative SaaS-based workflow management solution is transforming pharmaceutical manufacturing to enable agility and innovation in personalized medicine.

SOLUTIONS

Integrated Pharmaceutical Services: A Full Range Of Solutions

It's Time To Intensify: Embrace Process Intensification Today

Greener Supply Chains From A CMO Powered By Pfizer

Cryovial Aseptic Filling Platform: cryoFIL®

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