Newsletter | September 11, 2026

09.11.26 -- Europe's ATMP Opportunity Still Requires Local Navigation

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Protect What Matters in ADC Manufacturing

ADC manufacturing introduces complex challenges that can impact product quality, process consistency, scalability, and operator safety. Sartorius helps innovators and CDMOs reduce risk with closed, automated, and scalable solutions designed to protect what matters most. Reduce aggregation and variability, improve process reproducibility, and minimize exposure risks with integrated workflows that support reliable performance and safer operations. Enable scalable ADC manufacturing from development through commercial production. Learn more here.

FOCUS ON SUPPLY CHAIN

Europe's ATMP Opportunity Still Requires Local Navigation

European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.

 

 

Four Common Types Of Cryogenic Studies For Advanced Therapies

Learn why cryopreservation studies are so critical and how biopharmaceutical manufacturers can more easily navigate the complexities of this process.

 

Solutions Supporting Freezing And Storage Operations In Manufacturing

Practical strategies for reducing handling steps, minimizing product loss risk, and improving operator efficiency in frozen drug substance cold chain operations.

 

PTFE Containment: Viable For Temperature-Sensitive Protection

See why single-use cold-chain containers made with polytetrafluoroethylene fluoropolymers may be less susceptible to failure and breakage at cold temperatures.

SUPPLY CHAIN SOLUTIONS

Accelerated Delivery Of Manufacturing Capacity - FUJIFILM Biotechnologies

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Webinar: Improving Scale-Up Starts With Expression Strategy

Struggling with difficult recombinant proteins? Early expression challenges can lead to costly delays, uncertain scalability, and wasted development resources. This Primrose Bio webinar explores how expression screening and strain engineering can help identify risks sooner, evaluate manufacturability, and guide confident candidate decisions. Discover how Pfenex Expression Technology® can complement E. coli and CHO to uncover alternative paths for challenging molecules and accelerate development. Click here to learn more.

FOCUS ON PROCESS ENGINEERING

 

Advancing Cell Culture Strategies To Accelerate Biologics Development

Integrated stable expression strategies accelerate biologics material generation, improving scalability, consistency, and early developability insights while reducing bottlenecks and risks.

 

5 Minutes With: Jeff Goldman, General Manager

A look at the motivations, challenges, and vision shaping a new approach to life science tools—focused on practical design, thoughtful engineering, and expanding access to technologies.

 

Using Digital Tools In Process Development

Technology can transform the entire biopharma production process chain. Using integrated process models, machine learning, and genetic algorithms has made production faster and more efficient.

 

Novel Cardiotoxicity Evaluation Method Using iPS-Derived Cardiomyocytes

Discover how real-time monitoring of glucose and lactate in iPS-derived cardiomyocytes reveals subtle drug-induced metabolic shifts that traditional screening methods often fail to detect.

 

EV Content Vs. Function: Using Analytical Tools To Reveal The Connection

Examine how downstream processing affects CD73 expression and function on MSC-EVs through orthogonal analytical methods that connect vesicle content to biological activity and therapeutic potential.

 

When Your Expression System Isn't Cooperating With Your Protein

When a protein resists an established expression system, the issue may be host-platform mismatch rather than a fundamentally difficult molecule.

 

Life Cycle Assessment (LCA): Empowering Sustainable Decisions

Take a look at how Life Cycle Assessment converts environmental data into practical insights, helping improve product development, sustainability strategies, and decision-making.

 

Practical Considerations For Your Process Characterization Study

Outsourced process characterization can save time, but only with the right preparation. Clear expectations around materials and data interpretation help reduce rework and strengthen confidence.

 

Performing Virus Clearance Studies With Retroviral-Like Particles

Updated regulatory standards now support using non-infectious retroviral-like particles for viral clearance. This shift reduces costs and accelerates timelines for biomanufacturers.

 

Optimize DNA Clearance In High-Salt, GMP-Grade Purification Processes

Efficient hcDNA removal is vital for therapeutic safety and compliance. Explore how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.

 

Process Intensification: Your Guide To "Doing More With Less"

Uncover innovative strategies in process intensification to boost mAb production and hear from industry experts as they share solutions for scaling efficiency and navigating regulatory challenges.

 

Measuring Thermodynamic Parameters In The Drug Development Process

Join Dr. Ladbury to understand how thermodynamic data can enhance our understanding of protein-ligand interactions and how it is crucial for optimizing drug efficacy and safety in development.

 

Clean, New, Bioenergy Sources: One Molecule At A Time

Conversion of cellulose to bioethanol has huge potential to positively impact the global energy crisis, helping enable a shift away from fossil fuel dependency.

 

Unlocking Efficiency In Large-Scale Microbial Manufacturing

Gain insights into how expert teams and the right tools help build resilience into manufacturing systems and tackle small, often-overlooked issues before they become costly problems.

 

Developing New Medicines Through Artificial Intelligence

Embrace the future of drug development by leveraging AI and innovative protein synthesis technologies to accelerate the creation of effective therapies and transform patient outcomes.

 

Engaging Early In Process Development To Bring mRNA Sequences To Life

Delve into why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.

 

Real-Time Viable Particle Detection For Definitive Root Cause Investigation

Investigations into viable air excursions are difficult to perform using traditional methods. Find out why a real-time viable particle counter is key to providing process improvement.

PROCESS ENGINEERING SOLUTIONS

Enabling Large-Scale Lentivirus Manufacturing With A Reliable Stabilizer - Mirus Bio

Scaling Biologics With Confidence: Late-Stage To Commercial - Thermo Fisher Scientific

Why Lab Operations Need More Than Disconnected Tools - Revvity Signals Software, Inc.

Recombinant Protein Process Development And Scale-Up - Cytiva

20% Ethanol With WFI In Single Use Bags - Greenfield Global

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