July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing

Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

In Bioprocessing, Trusted Data Is A Process Variable

As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.

Are Biopharma Companies Outsourcing Their Ability To Think?

Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.

Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring

Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)?

Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.

Filtration: The Overlooked Enabler Of Process Intensification

Process intensification depends on more than facility changes. Smarter choices can help improve yield, throughput, and sustainability, turning an often-overlooked step into a meaningful contributor.

Process Intensification And Other Ways To Adapt To Changing Needs

As biologics manufacturing evolves, gain insight into why productivity depends on smarter investments, flexible production strategies, and supplier support that can address shifting modalities.

Exploring Takeda's Template For Sustainable Steam Generation

Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.

Transforming Computer System Validation In The Life Sciences Industry

Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.

Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis

Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

A Sterilizing-Grade Membrane For Efficient Filtration Of Biologics

Higher flow rates and a smaller process footprint can create meaningful gains across sterile filtration steps. Explore the performance data and where efficiency improvements may be possible.

An Open-Source Modeling Tool For Suspended Continuous Lyophilization

Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.

A Scalable Analytical Method For Quality-Driven AAV Characterization

AEX-HPLC has emerged as a robust, GMP-compatible analytical method for accurately characterizing AAV capsid composition, enabling consistent assessment of empty, partial, and full capsids to support product quality, process development, and regulatory readiness.

Step Into The Future Of Chromatography Automation

As downstream processing grows more connected and complex, chromatography remains a key automation challenge. See how greater flexibility and stronger control are shaping more practical workflows.

Process Intensification Through Downstream Connectivity

See how downstream steps can be linked into a coordinated workflow, with practical insight into automation, equipment integration, and process control for building a more efficient strategy.