Newsletter | October 23, 2026

10.23.26 -- The FDA's AI Religion: Elsa Dons A HALO

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Webinar: Rethinking Facility Design For The Reality Of Complex Biologics

As demand for complex biologics grows, integrated facility and equipment design is becoming essential to reducing risk, improving yield, and maintaining process reliability. In this webinar, experts from Jubilant HollisterStier and groninger explore how alignment across facility design, line architecture, and automation can support consistent manufacturing of complex biologics and lyophilized products, featuring JHS’s Spokane expansion as a case study. Click here to learn more.

INDUSTRY INSIGHTS

Unlocking The Potential Of Capsule-Based Dry Powder Inhalers

Dry powder inhalers offer major delivery advantages, but realizing their potential requires expertise across development, analytics, and production.

Spray Dry Biologics For Oral Dosage Forms

Spray drying enables stable oral delivery of biologics by creating protective dry powders, improving bioavailability, stability, and targeted release compared with traditional formulation methods.

The New Reality Of Particulate Risk: What Drug Manufacturers Need To Know

Particulate-related recalls account for 37% of US FDA injectable drug actions, and evolving FDA and EU GMP requirements are raising the compliance bar for manufacturers.

FEATURED EDITORIAL

The FDA's AI Religion: Elsa Dons A HALO

The FDA calls on your CDMO; inspectors are fortified by data in AI models, and appear practically clairvoyant. “It won’t be like the ‘old days,’” says David Grote of GrayMatters Partners, an organization that advises on quality systems and inspection readiness. The agency earlier rolled out Elsa, an AI-enable data architecture. Now its added an impressive HALO - Harmonized AI & Lifecycle Operations for Data.

AI Pilots And Strategic Partnerships

Geopolitical uncertainty is reshaping outsourced manufacturing. Discover how industry leaders are leveraging AI, enhancing partnerships, and strengthening supply networks.

INDUSTRY INSIGHTS CONTINUED

Advancing High Potency Manufacturing

Advance potent drug manufacturing through tighter containment, thoughtful process engineering, and closed handling that protects workers while improving efficiency and scale.

From Early Feasibility To Commercial Control Strategy

Discover how science, modeling, risk assessment, and DoE turn spray-dried dispersion scale-up from trial-and-error transfer into a predictable, robust path to commercial manufacturing.

Accelerating Discovery Success With Structure-Guided Drug Design

Structure‑enabled drug discovery revealed a novel, druggable binding site in Artemis, enabling rapid SAR optimization and a ~500‑fold potency improvement against a challenging oncology target.

From LAL To rFC: The Evolution Of Endotoxin Testing

Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.

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Join us on October 28 for Advancing Drug Substance Manufacturing and Small Molecule Drug Product Innovation sessions. Explore the science, technologies, and expertise driving small-molecule development, from API process development and technology transfer to formulation, manufacturing, scale-up, and packaging. Leading CDMOs will share strategies for evaluating manufacturing partners, mitigating development risks, and advancing programs from early development through reliable commercial production and patient-ready products.

SOLUTIONS

Packaging Solutions Built To Advance Your Mission

From Formulation To Global Supply: Mastering Oral Solid Development

Expertise In Solid Oral Dose Contract Manufacturing And Packaging

De-Risking Drug Development With PBPK Modeling

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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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