Newsletter | August 28, 2025

08.28.25 -- The Building Blocks Of A Robust Analytical Assay

INDUSTRY INSIGHTS

Kick It Off Right: A Successful Cell Bank Manufacture

Learn about best practices for cell bank manufacturing, how to get the most out of your cell bank, the future of closed processing in line with Annex 1, and more.

Filtration Methods To Overcome New Challenges In Viral Safety

This study offers valuable insights to guide informed decisions in virus filtration, aligning with both the PDA TR-41 (2022) and ICH-Q5A guidelines.

FEATURED EDITORIAL

The Building Blocks Of A Robust Analytical Assay

Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities

The pharmaceutical injectable manufacturing sector is experiencing unprecedented transformation through lean manufacturing adoption. This analysis examines current implementation trends, productivity impacts, and quality integration strategies based on data from leading pharmaceutical organizations.

Minimizing The Impact Of Human Errors Using Relational Risk Analysis

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.