Biosimilar App Notes & Case Studies

  1. Scale-Up Of AAV Production In Fixed-Bed Bioreactors 3/31/2026

    Consistent AAV production is critical for manufacturing. See how aligned strategies deliver comparable cell growth, metabolic trends, and rAAV5 titers from development through production.

  2. Application Of A Dual Spiking Strategy In Viral Clearance Studies 2/3/2026

    Explore how an alternative spiking strategy can streamline viral clearance studies, reduce material demands, and maintain compliance while addressing the challenges posed by MLV and MMV.

  3. Assessing Particle Generation In A Single-Use Mixing System 11/13/2025

    Explore how particle levels remained stable during 24 hours of high-speed mixing, even under extreme temperatures, confirming a system’s suitability for final fill and other particulate-sensitive applications.

  4. Evaluation Of Extractables And Physical Compatibility Of The Mobius® ADC Reactor Single-Use Components For ADC Manufacturing 10/29/2024

    Explore study results evaluating the physical compatibility of single-use components in the Mobius® ADC Reactor and the level of extractables when exposed to dimethyl sulfoxide and dimethyl acetamide.

  5. Cell Culture Media Filtration: Evaluating Cell Culture Performance 10/23/2025

    Cell culture performance remained consistent across PES and PVDF filters, even under worst-case filtration conditions. Discover a practical framework for evaluating membrane impact on CHO cell growth.

  6. Mild pH Protein A Purification Step With A Mild Elution Resin 5/22/2026

    As antibody formats diversify, low-pH protein A elution can drive aggregation and yield loss. Learn how milder elution conditions during capture can help protect sensitive molecules and ease challenges.

  7. Oligonucleotide Purification And Synthesis 1/27/2026

    Examine how a 21‑mer oligo was synthesized and purified through systematic resin screening, method optimization, and successful scale‑up to build reliable, high‑purity chromatography workflows.

  8. Performance Of Mobius® Bag Assemblies With Ultimus® Film In Truck Shipping Simulation Test 10/29/2024

    Explore findings from a study testing Mobius® single-use bags under rigorous shipping conditions, demonstrating the suitability for transporting various liquid volumes while preserving their integrity.

  9. Evaluating Antibody Fragment Purification Using VH3 Resin 5/22/2026

    Explore how VH-domain targeting enables efficient purification of VH3 antibody fragments and bispecific formats, with strong recoveries and flexible wash conditions that support improved purity.

  10. Optimizing TFF And SPTFF For High-Concentration mAb Formulations 4/9/2025

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