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September 2026 Issue is Now Live!

 
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September 2026

Features

Understanding the Pathway from Vial to Prefilled Syringe

Early planning can help drug developers manage the technical, manufacturing and patient-use challenges of transitioning from a vial to a prefilled syringe.

Features

The CDMO Capacity Crunch Persists

Nearly half of biopharma companies report difficulty finding mammalian production capacity, while cell and gene therapy face even tighter constraints.

Features

Safely Scaling High Potency API Manufacturing

The four risks that define successful HPAPI manufacturing.

Features

Pricing Molecules with AI: What Molecular Structure Can—and Cannot—Predict

Can the price of pharmaceutical molecules be predicted by artificial intelligence alone from molecular structure?

Features

Modeling & Simulation: Why Adoption Stalls in Pharmaceutical Development and Manufacturing

Why cost, data readiness, company culture and trust continue to limit broader use of modeling and simulation across pharma development and manufacturing.

Features

Inside the Changing HPAPI Manufacturing Landscape

Highly potent compounds are reshaping CDMO expectations, from early risk assessment to closed, automated containment facilities.

Features

Implementing a Risk-Based Quality Management System: Principles, Practice & Regulatory Expectations

How integrating risk-based thinking into everyday quality processes can strengthen compliance, decision-making and product oversight.

Features

High Concentration Large Molecules for Subcutaneous Delivery

Formulation, manufacturing and delivery strategies for high-dose biologics administered subcutaneously.

Features

From Clinical Success to Commercial Readiness: Preparing Emerging Modalities for Launch

Serialization planning, data visibility and partner connectivity can help biopharma companies prepare complex therapies for commercial scale.