Newsletter | October 3, 2025

10.03.25 -- Why Pharma, Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

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Webinar: From First-in-Human to Proof-of-Concept — Quicker, Smarter, Streamlined

Unlock the keys to successful First-in-Human studies with Quotient. This webinar reveals how expert-designed SAD/MAD trials, flexible CMC strategies, and smart regulatory planning accelerate proof-of-concept while avoiding costly setbacks. Gain insider insights on biomarkers, patient recruitment, and data integration—plus real-world case studies across rare diseases, obesity, CNS, and inflammation. De-risk early development and keep your program moving forward. Click here to learn more.

INDUSTRY INSIGHTS

Pharmaceutical Spray Drying – Technology And Applications

Explore the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.

Benefits Of A Liquid-Filled Capsule Dosage Form In Clinical Trials

Discover how a liquid-filled capsule dosage form can be a solution for poorly soluble drugs, while accelerating development timelines and reducing costs.

Getting To The Heart Of CDMO Tech Transfer Excellence

Here, we outline five key factors that drive a seamless and efficient technology transfer, highlighting how technical expertise, customer focus, and operational flexibility are crucial to CDMO success.

FEATURED EDITORIAL

Why Pharma, Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

When To Consolidate CDMOs ... And When You Shouldn't

A supply chain expert with decades of experience says that "from a pure supply chain perspective, we always try to "have universal drug substance, universal drug product and try to differentiate in packaging." But that doesn't always work out ... 

The Mighty CDMOs Producing API

CDMO focused on active pharmaceutical ingredients (APIs) have long been vital components in the supply chain. Today, they are more than your enablers. CDMO have become strategic actors helping to reshape global outsourcing markets. A new report focuses on the new forces raising their importance.

INDUSTRY INSIGHTS CONTINUED

Key Considerations For Dry Powder Inhalation

A focus on spray-drying expertise in pulmonary and nasal powder development highlights why it is vital to choose the right CDMO.

Preclinical Step To Assess Targeted Therapies For Primary, Metastatic NSCLC

To enable comprehensive evaluation of therapies targeting both primary and metastatic tumors, we've developed dual-disease xenograft models using bioluminescence imaging (BLI).

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Take a tour of Nanoform's best-in-class nanodevelopment capabilities, setting new standards in innovation. Their highly specialized team excels in creating unique nanoparticles for both small and large molecule APIs. With 14 development lines for small molecules and 5 for large molecules, Nanoform offers unmatched scalability and precision. Leveraging cutting-edge technology, they produce nanoformed materials as small as 10 nanometers. Learn more

SOLUTIONS

Computer Software Assurance (CSA) And Computer System Validation (CSV)

Kneat: Data Ready offers not only templates, but a validated out-of-the-box configuration that you can tailor to your business needs. Implement your Kneat instance in less than half the time.

Sterile Drug Product Development And Manufacturing

With nine manufacturing sites across five countries, our network supports the discovery of new chemical entities through commercial programs, while simplifying outsourcing with regulatory expertise.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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