Newsletter | August 6, 2026

08.06.26 -- Achieving Annex 1 Compliance In Sterile Manufacturing

INDUSTRY INSIGHTS

Accelerating Bulk Harvest Testing Using A CHO AOF Virus Panel

Here, we describe the design and performance of a degenerate PCR-based approach to broad virus screening that can be used in testing bulk harvest material derived from CHO cells.

FEATURED EDITORIAL

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.

Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program

In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

SOLUTIONS

A Single-Use, Automated Depth Filtration System