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| Phasing out animal testing in biologics safety is no longer a distant goal; it’s an actionable strategy. This application note explores a roadmap built on the internationally recognized 3Rs principles—Reduction, Replacement, and Refinement—plus a fourth: Responsibility. It prioritizes mature alternatives like NGS and the Blazar® platform, while accelerating innovation for complex assays such as tumorigenicity and oncogenicity. It also highlights evolving regulatory guidance, which increasingly endorses molecular methods over in vivo testing. More. |
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By Bioprocess Online Live | In this segment from the Bioprocess Online Live event “Ensuring Successful Technology Transfer In ADC Development,” panelists Sourav Kundu, Ph.D., and Will Olughu, Ph.D., respond to audience questions and reflect on poll results that identified tacit knowledge as the most difficult aspect of a process to transfer effectively. | |
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| Biologics CDMO Selection: Timeline Risks To Watch | Article | By Ralf Otto, Rezon Bio | Choosing a biologics CDMO means planning for timeline risks. Early evaluation of materials, batch release, technical flexibility, transparency, and partnership can help prevent delays. |
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| A Platform For Advanced AAV Analytics | Article | Andelyn Biosciences | Advanced AAV analytics use high‑resolution multiplex platforms to assess genome integrity and capsid traits, improving accuracy, speeding development, and supporting regulatory quality control. |
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| CHO Cell Line Characterization | Poster | Minaris | Biologic lot testing spans bulk harvest to final stability. Core panels check purity, safety, identity, and potency to ensure compliance, low risk, and high product quality across production. |
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| Restarting A Manufacturing Campus And Revitalizing A Community | Case Study | By Adam Covitt, Federal Equipment Company | A high‑risk facility acquisition in Huntsville became a blueprint for revitalizing a modern pharmaceutical campus. Discover how coordinated action turned a massive shutdown into a renewed manufacturing hub. |
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