Newsletter | January 28, 2026

01.28.26 -- Why Use Total Organic Carbon Analysis For Cleaning Validation?

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Webinar: Four Common Pitfalls to Avoid in UF/DF Setup and Scale-Up

UF/DF scale-up shouldn’t be where good processes fall apart. In this Repligen webinar, uncover four costly UF/DF pitfalls that derail programs—from membrane selection missteps to manual-heavy systems and PD–MSAT disconnects. Learn how early decisions impact scalability, timelines, and risk, and walk away with actionable strategies to build robust UF/DF processes that transfer smoothly to manufacturing. Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

Why Use Total Organic Carbon Analysis For Cleaning Validation?

Part of the Cleaning Validation For The 21st Century series

Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

Achieve Higher Targeted Concentrations

Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

Charged For Action: The Hidden Secrets Of AEX Oligonucleotide Analysis

Understanding how to fine-tune pH and ionic strength allows for the detection of truncated sequences and single-nucleotide variants, turning complex purification challenges into reproducible data.

Sterile Gas Filtration And Optimization In Bioprocessing

Unlock insights into sterile gas filtration challenges in bioprocessing. Watch this on-demand session to learn optimization strategies for critical applications and improved filter performance.

Safe Handling Of Monoclonal Antibodies: Best Practices

Explore safety measures for handling mAbs in production in order to meet strict requirements that prevent contamination, product loss and exposure to cytotoxic agents or radioisotopes.

Ion Exchange Chromatography Explained: Techniques & Uses

Chromatography resins are the core of any purification process. Gain insights into the selection process and other factors to consider when setting up your Ion Exchange Chromatography protocol.

Characterization Of A mAb, Associated Antigen-Binding Fragments

Size homogeneity of a mAb in solution is crucial for comparability and characterization. Here, an IgG1 antibody was cleaved into antigen-binding fragments via pepsin and papain digestion, then purified.

DOWNSTREAM MANUFACTURING SOLUTIONS

Drug Product Filtration System - Cytiva

Protein Capture Devices For Antibody Purification - W.L. Gore & Associates

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Join us for February's Bio-Expo Live, a three-day virtual event designed to empower biopharma professionals with the chance to conveniently explore the newest equipment and offerings in Upstream Bioprocessing, Downstream Bioprocessing and Bioprocess Quality, Data, and Analytical Solutions. Registration is free, reserve your spot today!

FOCUS ON FILL-FINISH

Atmos Isolator For Fill/Finish Applications

Examine a next-generation isolator that combines intuitive design and advanced automation that deliver unmatched sterility assurance and efficiency for aseptic processing.

The Evolving Landscape Of Fill/Finish: Trends, Challenges, What's Ahead

Discover how surging demand for GLP-1 and other therapeutics is transforming fill/finish capacity and regulatory standards. See how CDMOs are adapting to the complex needs of emerging modalities.

The Path To Self-Administration: Moving From PFS To Auto-Injector

Review advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.

FILL-FINISH SOLUTIONS

A New Player With A Long History - Andelyn Biosciences

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