Newsletter | January 7, 2026

01.07.26 -- Combining AI With Operations Research To Advance Biomanufacturing

FOCUS ON FILL-FINISH

Navigating The New USP Chapter <382> For Elastomeric Closures

Dive into the scope of <382> for pharmaceutical closures and the regulatory landscape, which includes new required tests, instrumentation for compliance, and recommendations on implementation.

Challenges And Solutions In Lyophilization Development For ADCs

Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

FILL-FINISH SOLUTIONS

Aseptic Connectors - CPC

FOCUS ON DOWNSTREAM MANUFACTURING

Combining AI With Operations Research To Advance Biomanufacturing

 In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tinglong Dai, Ph.D., Bernard T. Ferrari Professor of Business at Johns Hopkins University, and Tugce Martagan, Ph.D., associate professor at Northeastern University, to talk about the potential advancements that can be made in biomanufacturing by combining AI with operations research (OR).

The Hidden Threat To Product Purity: Neglected Seals In Synthesis Columns

In biopharmaceutical manufacturing, seemingly minor components like seals can pose significant risks to product purity. Overlooking them can lead to contamination and costly delays.

Improving Productivity And Purity In ADC Polishing

Discover how a CDMO achieved 40x productivity and 15% cost savings by switching to rapid cycling membrane chromatography for ADC polishing, which helped cut process time and buffer use.

Tips For Designing A Single-Use Manifold For Advanced Therapies

Expert single-use engineers address six common questions posed by cell and gene therapy manufacturers in the design of custom single-use manifolds for the critical handling of biological fluids.

Demonstrating A Modular Selectivity With A Weak AEX-HIC Resin

Learn how a scalable multimodal resin with adjustable selectivity was employed to design an efficient mAb purification process in a flow-through mode.

Manual TFF: Lab Scale Chaos To Controlled Success

Not all TFF systems are created equal. Explore how automated solutions eliminate manual chaos, improve reproducibility, and scale with ease.

DOWNSTREAM MANUFACTURING SOLUTIONS

Bio-Expo Live November 2025: Downstream Bioprocessing - Ecolab, Purolite Resins

Scale Up: Supporting Easy Scalability All The Way To Manufacturing - Cytiva

Chromatography Consultation Tools For Process Intensification - Sartorius

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