Search results for " development" in Articles / App Notes
Article
Manufacturing of Vaccines and Viral Vectors
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With the pandemic outbreak of COVID-19, there is intense focus on developing a vaccine. However, the challenge not only lies in developing a vaccine but also i…
Article
Getting Ahead of the Game in Cell and Gene Therapy
Successes in the clinic have placed many cell and gene therapies on an accelerated route to market. But unless developers consider, at an early stage, how they might produce their product at scale, th…
Article
Mechanistic Modeling of Chromatography: Opportunities and Challenges
Explore opportunities and challenges of an approach that can help make process development become faster, more scientific, and more reliable.
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Article
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…
Article
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.
Article
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…