Newsletter | November 6, 2025

11.06.25 -- A 5-Step Guide To Achieving Your Biosimilar Milestones On Time

INDUSTRY INSIGHTS

A 5-Step Guide To Achieving Your Biosimilar Milestones On Time

As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

How To Fingerprint Cell Culture Media

Ensuring media identity and consistency is vital in biologics manufacturing. Discover why quantifying cell culture media components before batch release helps overcome formulation complexity.

FEATURED EDITORIAL

Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

Should We Refocus On The Product, Then Engineer The Process?

Logic behind the "process is the product" refrain collapses when you accept that starting material is non-uniform by design. These experts want to rethink a tired cliche.

SOLUTIONS

PEI And Non-PEI Transfection Solutions For High Titers And Production

Pre-Use Post Sterilization Integrity Testing (PUPSIT) Overview