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| Developing a scalable, GMP-ready AAV8 production platform is complex and requires a unified approach across upstream and downstream operations, data-driven decisions, and efficient progression from bench scale to manufacturing-relevant volumes. In this white paper, Matica Biotechnology and Sartorius demonstrate how collaboration enabled the design, optimization, and scale-up of an integrated AAV8 process to 50L with reproducible performance, sharing practical lessons in upstream optimization, downstream purification, capsid separation, and analytics to support flexible gene therapy manufacturing. |
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By Devendra Ridhurkar | When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together. | |
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| 3 Decision Domains Shaping Sterile Drug Product Success | Article | Thermo Fisher Scientific | In sterile development, the decisions with the greatest downstream consequences are rarely recognized as such when they are made. Examine how these choices shape program outcomes across the lifecycle. |
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| Benefits Of Isolator Technology In Fill-Finish | Article | By Sabrina Zirkle, Jubilant HollisterStier | Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations. |
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FOCUS ON DOWNSTREAM MANUFACTURING |
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By Bioprocess Online Live | In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), reflect on the progress that’s been made in terms of productivity gains and the “ceiling” that mAbs face, and how these upstream gains stress downstream operations. They also discuss how molecular complexity relates to challenges in purification. | |
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| High-Throughput Innovation In Action | Infographic | WuXi Biologics | Explore the growing demand for high‑concentration biologics, and the formulation, viscosity, and manufacturing challenges driving new technologies for stable, scalable drug development. |
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| SPTFF High Concentration mAb Formulation | Case Study | By Chris Marlein, Matthew Dillingham, Evie Wood, et al., FUJIFILM Biotechnologies | Gain insight into how single-pass tangential flow approaches improve efficiency, scalability, and product quality while addressing key development and processing challenges. |
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DOWNSTREAM MANUFACTURING SOLUTIONS |
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