Newsletter | May 13, 2026

05.13.26 -- Expanding The IV → SC Framework: What Reformulation Really Means

SPONSOR

Webinar: Supporting Efficient mAb Development with a Flexible Downstream Purification Toolkit

Accelerating antibody therapeutics to market requires more than upstream performance. As mAb formats grow more complex, downstream purification must evolve beyond traditional approaches. This webinar explores flexible purification strategies, advanced chromatography options, and buffer optimization techniques to improve yield, purity, and robustness. Learn how to streamline process development and build a purification toolkit that supports faster biologics manufacturing. Click here to learn more.

FOCUS ON FILL-FINISH

Expanding The IV → SC Framework: What Reformulation Really Means

IV → SC is a system design challenge. Success depends on aligning formulation, device, manufacturing, and clinical strategy early to avoid costly failures and redesigns.

ITC: Unveiling Its Role And Importance In Drug Design

Explore how Isothermal Titration Calorimetry empowers drug discovery, as well as learn about ITC fundamentals, how to eliminate weak candidates, and how to optimize development decisions.

Small Volume ATMP Cryo-Freezing Strategies

Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.

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.

Product Recovery Study For Fill Finish Applications

Surge bags are essential to fill finish efficiency, but poor drainage can cause costly product loss. Learn how drainage testing helps identify high-performance bags that maximize recovery and reduce waste.

FILL-FINISH SOLUTIONS

GMP Recombinant Human IL-15 - Miltenyi Biotec

FOCUS ON DOWNSTREAM MANUFACTURING

Gamma Delta T Cells Explained: The Next Medical Breakthrough?

Gamma delta (γδ) T cells are emerging as a promising new frontier in cell therapy, offering potential for treating both solid tumors and autoimmune diseases.

Tool Enzymes For Antibody-Drug Conjugate Development And Manufacturing

See how modern tool enzymes enable cleaner, more consistent ADC conjugation, sharper analytics, and a smoother path from research to clinical development — practical guidance for manufacturing.

Optimizing TFF And SPTFF For High-Concentration mAb Formulations

Examine the role of formulation buffer composition in stabilizing mAbs during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.

Why Anion Exchange Chromatography Rules At Scale

Read about how anion exchange chromatography delivers high loading capacity and clinical-grade purity while addressing common scale-up challenges like aggregation and equipment longevity.

Eliminate Downstream Bottlenecks In Antibody-Based Therapies

Organizations seeking greater efficiency within their downstream purification processes are well-served in considering a single-use, membrane-based solution in lieu of resin-based purification columns.

Antibody-Drug Conjugates: Manufacturing Precision Medicines

The monoclonal antibody intermediate is engineered for precise delivery of the linker-payload complex. Find out how rigorous storage measures ensure its quality, which is crucial for successful conjugation.

DOWNSTREAM MANUFACTURING SOLUTIONS

Predicting CHO Retroviral Particle Clearance - Cygnus Technologies Inc.

A High-Capacity Chromatography Resin For Robust mAb Capture - Cytiva

Blood Infusion Syringe Filter For Microaggregate Removal - Charter Medical

Field Application Services: Our Chromatography Experts - Ecolab, Purolite™ Resins

Connect With Bioprocess Online: