Search results for " productivity" in Articles / App Notes
Article
Antibody Production Workflow
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Antibody-based therapies have evolved beyond monoclonal antibodies (mAbs) to include bispecific antibodies, antibody fragments, antibody-drug conjugates (ADCs), and m…
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See How Solis BioDyne Turned to Cytiva to Support Production Ramp-Up
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Solis BioDyne is one of the many life sciences companies that experienced a dramatic increase in demand for its solutions during the COVID-19 pandemic. In a collabora…
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Understanding Protein Production from Start to Finish
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In protein research, going from idea to pure characterized protein takes multiple steps and techniques. Most scientists working with exploring proteins and developing spe…
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Increasing Productivity in Hydrophobic Interaction Chromatography (HIC) Using Capto™ Resins
In this study, the hydrophobicities of newer-generation Capto™ HIC resins were compared to Sepharose™ High Performance and Sepharose Fast Flow HIC resins. An application example is also present…
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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QbD and PAT in Upstream and Downstream Processing
There are key performance indicators (KPIs) that are defined for upstream steps, including culture productivity (i.e., titer), cell growth, and viability. While KPIs may be correlated with CQA results…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Historically, suitability has been evaluated utilizing phenotypic measures (productivity) assessing cell-line productivity across a generational span encompassing the manufacturing window. Given the v…
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Unifying Continuous Biomanufacturing Operations
Higher productivity per volume means companies can manufacture products at a faster rate. Lawrence Yu, PhD, deputy director in the Office of Pharmaceutical Quality at the Center for Drug Evaluation an…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…