Newsletter | January 30, 2026

01.30.26 -- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing

SPONSOR

BioPlan Associates is conducting its 23rd Annual Global Biopharmaceutical Manufacturing and Trends Analysis and needs your insights for the biopharma industry’s most comprehensive global benchmarking analysis! For over 20 years, BioPlan Associates has analyzed advances in bioprocessing, new technologies, and emerging trends, supported by global institutional and media partners. For all completed, qualified surveys, they'll offer an Amazon e-gift card, a copy of the summary results, and the 2026 Top Trends in Biomanufacturing White Paper.

INDUSTRY INSIGHTS

Unlock The Power Of Efficient Measurement Instrumentations

Explore how manufacturers can turn sustainability challenges into strategic advantages through smarter energy use, regulatory insight, and emerging innovations.

The Influence Of Economic Factors On Manufacturing

Understanding the complex effects of inflation, recession, and regulatory shifts is key to navigating the challenges faced by the biopharmaceutical manufacturing sector and ensuring its continued growth.

Cleanroom Changes In 2026 For Better Contamination Control

Proactively improve your cleanroom strategy. Gain actionable insights on leveraging Environmental Monitoring data, optimizing personnel, and managing residue to enhance contamination control.

FEATURED EDITORIAL

The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing

The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

INDUSTRY INSIGHTS CONTINUED

Aseptic Process Design And Simulation Under Annex 1 Guidelines

Delve into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.

Tablet Manufacturing Technologies For Solid Drug Formulation

Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting methods and excipients to achieve the desired stability.

Why Leaders Can't Afford Delays In Document Review

Document review is a hidden bottleneck in biopharma. Discover how inefficiencies in this critical process can delay drug development and what you can do to accelerate time to market.

Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation

Insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.

Predicting Hepatotoxicity With The Liver-Chip

Enhance your understanding of liver organoids and their pivotal role in enhancing DILI risk prediction through the use of advanced Organ-Chip technology.

CDMO Audit Coverage: Key Focus Areas And Compliance Objectives

CDMO audits focus on compliance, quality, performance, and relationships to reduce risk, ensure clear documentation, and align customer expectations with CDMO capabilities.

Streamline Your Fill And Finish Process Of Ready-To-Use Cartridges

An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics to improve efficiency in pharmaceutical production.

Comparison Of 96-Pin Extraction Device To Rapid Equilibrium Dialysis

Here, we review a technology that has been demonstrated to significantly reduce the time required for protein binding determination when compared with the rapid equilibrium dialysis method.

Antibody-Drug Conjugates: Next Generation Of Targeted Cancer Treatments

Manufacturing complex and highly potent ADC treatments presents unique challenges. Get an insider look at how these treatments make it from development to commercialization.

Supporting The Unique Needs Of Your Sterile Injectable

Leveraging the experience and specialized technology of a reliable CDMO partner is essential to ensure your sterile injectable therapeutic's safety and quality while delivering at speed.

SOLUTIONS

USP 661.1 Vs 661.2: Key Differences And Compliance

Expert Support For Container Closure Integrity

Package Testing Services

An Introduction To Validation Of Aseptic Fill/Finish And Related Processes

GLP-1 Receptor Agonist Solutions

A/L/P Assembly, Label And Packaging

Drug Substance API Manufacturing Network

Polymer Processing Capabilities

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