Newsletter | November 17, 2023

11.17.23 -- Risk Tool Selection With ICH Q9(R1) In Mind


What if you could achieve intensified perfusion processes with high cell densities in just 2 mL, saving you precious media and associated costs? With the Mobius® Breez microbioreactor, you can rapidly collect high-quality data sets by running multiple cell culture experiments simultaneously and independently on your benchtop with only 2 mL working volume. Find out how.


Risk Tool Selection With ICH Q9(R1) In Mind

This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios and what the team composition should look like.


Where Bioprocessing Outsourcers Stand On Capacity Concerns

Insights into bioprocessing outsourcers’ level of concern regarding current and upcoming available capacity, whether they are currently facing limits, and what they plan to do about a potential shortage.

The Colloidal Particle Adsorption (CPA) Model In IEX

Learn about an adsorption isotherm class that is based on a colloidal description of proteins and achieves increased accuracy at high column loading in IEX modeling.

Centrifugation Of High Cell Density Cultures: Mitigating The Impact Of Shear

Optimizing the harvesting process is crucial to avoid risk and complications in downstream operations. Explore how to rapidly assess the shear sensitivity of the cells and strategize mitigation plans.

Using Advanced Mass Spectrometry To Analyze APIs And Impurities

Learn about the growing role of CDMOs in supporting the development of advanced analytics products, including mass spectrometry, and how to optimize the analyte life cycle.

Using Machine Learning In Microscopy Image Analysis

Train your own machine-learning models for fast and reproducible image analysis and achieve easy image segmentation for instant and reliable results.

Robust mAb Capture At High Productivity

Four mAbs were tested on a novel chromatography membrane with a standard purification protocol. Explore study results and learn how this new technology can eliminate two pain points.

Key Considerations During A Merger Or Acquisition

Find out how a strategic partnership with a used equipment dealer can provide guidance through the process of a merger or acquisition of manufacturing facilities and simplify equipment removal and sales.

The Path To A Secure Supply Chain: 10 Questions To Ask

API supply is all about balancing risk. Preparing to ask and answer these 10 questions can provide clarity and confidence. Discover how to diversify your API supply chain.

Traditional Sensors, Single-Use Systems: Bridging The Connectivity Gap

The secure, leak-free connection of sensors to single-use assemblies is paramount in ensuring both the accuracy of the measurements taken and protection of the manufacture of expensive drug products.

Process Analytical Technology For Real-Time Bioprocess Monitoring

Explore applications and case studies where next-generation Raman technology was used for real-time, inline monitoring of cell culture process parameters.

Creating Aseptic Connections Between Bioreactors And ATF Systems

Learn more about alternating tangential flow (ATF) and the benefits of large-diameter aseptic connections between bioreactors with a 1 1/2” flow path.

Manufacturing Process Transfer: Challenges And Keys To Success

A successful technology transfer sets the stage for GMP production and opens the door to process performance qualification campaigns and licensure.



A Future-Proof Solution For Bioprocess Applications

Biopharmaceutical Process And Manufacturing Technology Services

Plant 5 Dream Plant: Within Your Reach. Built For Your Success.

Ajinomoto Bio-Pharma Services Capacity Update October 2023: Biologics

Software To Streamline Your Liquid Handling Processes


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