🏆 Top Story: Fox News Update

FEATURED EDITORIAL

The biopharmaceutical's “Valley of Death” is entered through a desert of dwindling funding. Chief Editor Louis Garguilo talks with two consultants on avoiding financial failure when outsourcing development and manufacturing. The many contributing factors for failure may have a common denominator: Project Management is an overlooked financial savior.

GUEST COLUMNISTS

Why We Need Pharmaceutical Engineering Project Management As A Distinct Discipline
Applying general project management to a regulated setting as a variant of PMP or PRINCE2 is one of the most consistent, and most avoidable, causes of cost overrun and delayed start-up.
Complete Response Letters For CGTs Share This Common Theme
One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.
Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
The Orange Book's Blind Spot: Process Stability And Capability
The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.
Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

PHARMA OUTSOURCING WHITE PAPERS

Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

Drug Substance Development: Applying Platform Knowledge Across Modalities
Upstream processes often transfer readily, while downstream purification and formulation require product-specific adaptation and expert judgment.
Manufacturing Oncolytic Viruses: Where Complexity Demands Experience
Dose, concentration, potency, purity, recovery, and cost are closely linked in oncolytic virus manufacturing. Learn why early alignment can prevent costly challenges.
Integrating Drug Substance And Drug Product To Reduce Risk In Development
Discover how integrated planning, shared analytics, and greater continuity can support stronger decisions from early development through commercialization.
High-Throughput Binding Affinity Assessment Using Octet® HTX
Binding affinity screening of clones directly from crude supernatant, without purification, changes what can be assessed early, and a tiered workflow pairs broad throughput with deeper analytical characterization.
Turning Oncolytic Viruses Into Manufacturable Cancer Therapies
Oncolytic virus manufacturing depends on preserving infectivity and potency. Materials, hold times, and product-specific analytics shape scalability well before GMP production.