Newsletter | September 13, 2025

09.13.25 -- Best Of August: Single-Use Standardization Starts At Home

AUGUST'S BEST FEATURED EDITORIAL

What Did ICH Q14 Miss On Analytical Method Validation?

Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.

Product Quality, Process Complexity, And Cost Control

Johnson & Johnson Senior Director Irina Ramos, Ph.D. joins Bioprocessing expert David Bruehlmann for this segment of the Bioprocess Online Live event Process Optimization or Full-Scale Automation. The two discuss differences in product quality between fed batch and continuous, handling disruptions and quality control strategies, and more.

How Modeling Predicts Bottlenecks In Takeda's Multimodal Facilities

A functional simulation requires many manual inputs, including data smoothing, vendor collaboration, and even direct communication with tenured employees who know the job best.

AUGUST'S BEST INDUSTRY INSIGHTS

Biopharma Production And Quality Control With Electrophoresis

Learn how Kaneka Eurogentec, a leading provider of custom DNA synthesis and molecular biology services, enhanced their fragment analysis to achieve higher efficiency and accuracy in their workflows.

Adopt An Automated And Data-Driven Approach To Cleaning Validation

Discover how digital transformation is revolutionizing cleaning validation, as well as how automation, data-driven tools, and compliance innovations are streamlining processes and ensuring success.

Indian Biosimilar Companies Are Poised To Succeed In The Global Market

For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.

AUGUST'S BEST SOLUTIONS

Formulation Development: The Key To Product Stability

Biologics Analytical Services

Increase Speed, Sensitivity, And Resolution With UPLC Column Technology

Connect With Bioprocess Online: