CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?

Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.

Why Your MES RFP Is Failing Before It Starts

Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

Why Dilution Gets Tricky: The Role Of Measurement Variability

Dilution's effects on downstream processes and final formulation is often understated. A statistical framework can quantify measurement uncertainty's impacts.

Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative

This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

The Stepwise Path Lilly Mapped From Paper To Digital Logbooks

Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

Selecting The Right eQMS To Maximize Quality Maturity

Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

Do Changes Signal The End Of Biosimilar Regulatory Redundancy?

First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.

FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing

The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

Life Cycle Assessment Of Extended Use Strategies For Single-Use Assemblies

Examine how extending the use of single‑use assemblies can significantly reduce emissions, resource consumption, and waste in bioprocessing, offering a data‑backed path toward sustainability.

U.S. Pharma Tariffs And MFN Become Law After April 2 Update

Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

FDA's New Flexible CMC Framework For CGT

The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

How To Implement Post-Approval Changes On A Global Level

To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

The Business Case For Continuous Manufacturing In Biologics

The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

Microbial Integrity Of Sampling Systems After Multiple Actuations

Repeated sampling doesn’t have to mean increased contamination risk. See how microbial ingress testing demonstrates sterility integrity after up to 50 sampling actuations.

From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations

Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.