Newsletter | March 8, 2025

03.08.25 -- Bioprocess Online Best Of February

FEBRUARY'S BEST FEATURED EDITORIAL

FDA Finalizes Guidance On AMTD Program

The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

Using Simple Spreadsheet DoE To Optimize The Protein Pipeline

Let's demystify the design of experiments approach with simple tools for implementing 2-level factorial experiments, including workbooks free to download.

Biomanufacturing Precision With Digital Twins & Mechanistic Models

During this Bioprocess Online Live, experts from Pfizer, Takeda, and Sanofi discussed how digital twins and mechanistic modeling improve biopharmaceutical processes and streamline new production line setups.

FEBRUARY'S BEST INDUSTRY INSIGHTS

The Guide To Understanding The Impact On Cost Of Poor Quality

This guide unveils the hidden financial burdens of subpar products and provides a roadmap to improvement. Explore nine distinct categories of poor-quality costs and learn strategies to mitigate them.

ICH Q14 101: Applying AQbD To CMC For Regulatory Success

ICH Q14 provides comprehensive guidance on analytical procedure development, offering an invaluable framework for ensuring the development of regulatorily compliant analytical procedures.

How Pierre Fabre Labs Enhances Their Antibody Developability Platform

Learn how Pierre Fabre Laboratories streamlined their antibody development with the implementation of a new platform, enabling efficient and multi-parameter stability measurements.

FEBRUARY'S BEST SOLUTIONS

An IoT Solution For A Reliable, Real-Time Informed Diagnosis

A Premium Sample Preparation System

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