Newsletter | November 4, 2025

11.04.25 -- Takeda Reimagines Biopharma Quality For The Digital Age

SPONSOR

New Whitepaper: Insights into MSC-Based Therapies

Discover key advancements in MSC-based therapies with insights from Corning's Field Application Scientists. Explore methods for MSC isolation, production considerations, media options, cell expansion technologies, and cGMP manufacturing. Gain valuable learnings from collaborations with academic researchers, biotech, and pharmaceutical companies, featuring real-world case studies. Whether you're scaling for clinical applications or advancing research, this whitepaper provides actionable strategies to optimize MSC production and push the boundaries of therapeutic development.

FOCUS ON MANUFACTURING

Takeda Reimagines Biopharma Quality For The Digital Age

Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it in real-world applications.

Process Impurities: Don't Let PEI Or HCP Derail Your Biotherapy

Learn advanced product characterization strategies to effectively de-risk manufacturing and accurately detect and characterize host cell proteins and polyethylenimine in mAb and cell and gene therapies.

High Purity And Recovery With Adjustable Selectivity In Downstream Purification

Discover a high-performance resin that enables high-yield purification of complex biomolecules, as well as supports fast flow rates, consistent recovery, and scalable performance for reliable downstream processing.

Finding The Right Aseptic Processing Approach

How should you approach building your aseptic processing line? Gain valuable insight into the advantages of using a modular, configurable technology platform rather than custom fill-finish solutions.

Simplified LV And AAV Clarification With TFDF-Based Intensified Virus Production

See how Tangential Flow Depth Filtration (TFDF) enhances viral vector production by streamlining the clarification process and significantly increasing efficiency and yield for LV and AAV manufacturing.

How To Identify Optimal Materials For Biopharma Single-Use Solutions

Have you thought about how the materials chosen for tubing, transfer sets, single-use bags, and manifolds in therapy manufacturing could enhance your processes, improve product integrity, and support compliance?

Engineering An AAV Platform For Superior Titer And Capsid Integrity

Assimilate how to optimize AAV manufacturing with a transfection reagent and enhancer platform that boosts titers and percent full capsids by 2- to 10-fold, featuring insights from real-world case studies.

Manufacturing CAR T Cell Therapies: Challenges, Insights And Solutions

Manufacturing patient-specific cell therapies is a complex, multi-step process. Addressing key hurdles in production time, scalability, and cost is crucial to making these vital treatments more accessible.

Transform Monocyte Based Cell Therapy Manufacturing Via Elutriation

Monocyte-derived immunotherapies provide a promising outlook on cancer treatments, but there are challenges during manufacturing. Consider the data and performance of a fully automated counterflow centrifuge system.

Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges

Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.

Benchmarking Filtration Performance Of TFF Cassettes

Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection in lab-scale systems.

SPONSOR

Join life sciences experts and global regulators this 9–10 December for the 2025 ISPE Pharma 4.0™ Conference in Barcelona, Spain, or virtually. This year's agenda spotlights how innovative enabling technologies including AI, machine learning, virtual and augmented reality, industrial internet of things, GxP cloud platforms, robotics, advanced modeling, and automation, are addressing key challenges like drug shortages and improving product availability.

MANUFACTURING SOLUTIONS

A Modern Pharma MES Solution Offers The Best Of Old And New - MasterControl, Inc.

Getting Started With Vertical-Wheel Bioreactors - PBS Biotech, Inc.

FectoVIR®-LV Transfection Reagent - Sartorius

Centrifuge Assembly - Entegris, Inc.

AES Box ™ Pharmaceutical Modular Cleanroom - AES Cleanroom Technology

Ascent® Fixed Bed Reactor System - Corning Life Sciences

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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