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| Watch On-Demand: A Scalable, Reproducible Solution for ADC Purification | Mixed-mode chromatography offers an effective solution for purifying antibody-drug conjugates (ADCs), addressing challenges such as aggregates and high DAR species to ensure both safety and efficacy. We highlight purification of an emtansine biosimilar ADC using ceramic hydroxyapatite media, enabling effective separation of monomeric ADCs from aggregates and over-conjugated species. This scalable, reproducible solution improves product quality and consistency for both biosimilar and novel ADC manufacturing. Watch now. |
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FOCUS ON DOWNSTREAM MANUFACTURING |
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By Tyler Menichiello, chief editor, Bioprocess Online | Coordinating unit operations can help reduce costs and mitigate challenges in process development. Check out these key takeaways from the Bioprocess Online Live event “Optimizing Process Development Through Upstream and Downstream Integration.” | |
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| Twist Of Two: 2D-LC For Oligos | Article | KNAUER | Gain insight into how coupling orthogonal mechanisms reveals hidden impurities and creates a more robust strategy for characterizing complex oligonucleotide samples. |
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| Considerations For High Productivity Membrane Affinity Chromatography | Application Note | By Neha Saxena, Ph.D., Shunsuke Shiina, Ph.D., and Rodrigo Gonzalez, Ph.D., AGC Biologics Inc.; Eric Van Voorhees and Hasan Hashemisohi, Ph.D., W.L. Gore & Associates | Explore results from a study aiming to identify hydrodynamic shear rate, cumulative shear stress, and Reynolds number values likely in high-productivity affinity membrane chromatography. |
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| Virus Reduction And Impurity Removal | Application Note | Bio-Rad Laboratories, Inc. | Examine a DOE-based study that reveals how buffer conditions impact virus and impurity clearance using a mixed-mode resin, as well as gain practical guidance for optimizing downstream purification. |
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| 3 Critical UF/DF Challenges And How To Solve Them | Webinar | Repligen | High‑concentration mAbs change how UF/DF behaves. Learn how modern TFF platforms help address these challenges and maintain control as formulations move beyond traditional limits. |
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| Maximizing Yield And Purity With Praesto™ CH1 Resin | Webinar | Ecolab, Purolite™ Resins | Discover a new resin designed to simplify antibody purification, improve yield, and enhance contaminant removal during the capture step—ideal for complex therapeutics and GMP workflows. |
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| Balancing Protein A Resin Cost, Performance, And Productivity | Application Note | By Niklas Jungnelius, Cytiva | Optimizing input parameters like DBC, flow rate, and resin durability is key to boosting productivity in downstream bioprocessing. See how to tailor resin choices to meet your specific process requirements. |
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DOWNSTREAM MANUFACTURING SOLUTIONS |
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| 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. |
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| USP Draft Chapters On CCS: What You Need To Know | Article | By Lauren Orme, West Pharmaceutical Services, Inc. | Review why it's important to stay aligned with evolving Annex 1 expectations to support sterility assurance, regulatory compliance, and patient safety across sterile drug manufacturing operations. |
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| What Is Aseptic Processing? | Article | Cytiva | Aseptic processing sterilizes products and packaging separately, then combines them in a sterile environment. This method ensures safety, extends shelf life, and protects medicines from contamination. |
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