Search results for "development"
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Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
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The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity br…
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Raw Material Variability: The Need for Deeper Process Understanding
Principles and methodologies for biopharmaceutical development and manufacturing are well established today. However, the increased molecular diversity and drive for higher productivity brings new c…
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
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Collaborative PD Outsourcing: Why Closer is Better
Sharing process details externally might seem too close for comfort, but when it comes to process development (PD) outsourcing, a close collaboration can actually bring added benefits.
Cl…
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Efficient and Scalable Buffer Preparation
This article describes how to ensure a scalable process for buffer management from process development to manufacturing with inline conditioning (IC). It also explains how Ä…
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Upstream PD Time-Saver: Optimize Early
Identify the right combination of culture medium, feed supplements, and feeding strategy early in upstream process development to conserve precious time and resources.
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Faster Flavivirus Vaccine Production
Surface Plasmon Resonance (SPR) analysis during process development provides data about virus behavior and host interactions. This is valuable both for regulatory compliance and future drug developmen…
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Scale-Up Model of a mAb Process from Microbioreactor to XDR-1000
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In process development, it is desirable to test process parameters in small scale and later scale up the process into larger production scale. A theoretical scale-up study was per…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
Nandu Deorkar, vice-president of research and development at Avantor, a manufacturer and distributor of products, services, and solutions to the life-sciences and advanced technologies industries.
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Case Study: Process for Production of Oncolytic Adenovirus
The promising results from clinical studies on the use of viral vectors to address important medical needs have spurred interest in developing scalable and cost-efficient manufacturing processes. Here…