Newsletter | October 31, 2025

10.31.25 -- On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

SPONSOR

ADCs: Advancements And Insights

As companies refine their approach to conjugation chemistry, scale-up, and clinical integration, the path forward requires both advanced technologies and strategic collaboration. This collection of insights, sponsored by ACROBiosystems, offers an illuminating view of the science, engineering, and quality considerations shaping the next generation of targeted cancer therapies. Learn more here.

FOCUS ON PROCESS ENGINEERING

From BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

Taking An Institutional Approach To PAT Implementation

In this segment from the Bioprocess Online Live event, “Aligning CMC And MSAT To Move PATs Out Of Pilot Mode,” our panelists emphasize the importance of strategic planning for PAT implementation and the value of cross-training. Mengyao Li, Ph.D., from Novartis suggests taking a stage-gated approach and starting with the “low-hanging fruit.”

Aggregation In Antibody-Drug Conjugates: Causes And Mitigation

Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.

Cell Culture Media Fingerprinting

Ensure consistency and quality in production with an advanced CCM fingerprinting technique that is capable of identifying over 100 media components to reduce variability and meet regulatory standards.

Optimization Of The Freeze Drying Process

Freeze-drying stabilizes biologics but requires optimizing parameters like temperature and structure. Explore how modulated DSC™ improves precision in analyzing transitions.

The Impact Of Tip-Based Systems And Jetting Technology

Discover how protein A resins with superior binding capacity and elution efficiency transform high throughput process development for mAb purification, optimizing results and reducing time to market.

Demonstration Of Scalability For A Novel Fixed Bed Reactor Platform

Designed to enable efficient scalability, a new FBR platform allows operators to use one technology, with a standardized workflow, for their process development, scale-up, and manufacturing processes.

The Coevolution Of The Single-Use And Biopharmaceutical Industries

Learn more about the evolution of one company's solutions for biopharmaceutical manufacturing and accelerating market entrance using single-use technology.

PROCESS ENGINEERING SOLUTIONS

Prometheus Panta For Your Automated Workflows - NanoTemper Technologies, Inc.

Process Liquids Preparation Services - Thermo Fisher Scientific Bioproduction

FGF-2 TOP GMP Thermostabilized Growth Factor - Nucleus Biologics

FOCUS ON SUPPLY CHAIN

Friendshoring: A Strategic Shift In Pharma Supply Chains

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

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