Search results for " specification" in Articles / App Notes
Article
Manufacturing of Viral Vectors
Viruses are infectious agents that can only replicate inside of living cells. This trait is used by molecular biologists for the delivery of genetic materials into cells. Viral vectors are also explor…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Since 2003, BioPlan Associates, Inc. of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity …
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How to Determine Dynamic Binding Capacity (DBC) of Chromatography Resins
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In protein purification, dynamic binding capacity (DBC) of a chromatography column describes the maximum amount of target protein that you can load onto your co…
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A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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The Challenge of Disruptive Technologies in Bioprocessing
The Challenge of Disruptive Technologies in BioprocessingIncreasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
Increasing demand for biologics is drivin…
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Biopharma Seeks Balance
For example, industry groups championed efforts to address technical issues related to materials specifications and extractables and leachables, helping to accelerate the adoption of single-use system…
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Interpreting Protein Binding Capacities for Chromatography Resins
In this post, we explain what protein binding capacity is, how it can be measured, and what to look for on a manufacturer's specification sheet.
Article
Modern Manufacturing Key to More Effective Vaccines
…y when combating epidemics, such as accepting supportive CMC data from platform-related products and specifications based on related products. Test vaccines also may be used prior to obtaining real-t…
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Preclinical Evaluation of Product Related Impurities and Variants
As a result, the commonly followed approach involves assignment of a specification for the variants based on statistical analysis of the levels seen during commercial manufacturing. Thereafter, monito…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
An interview with Aaron Noyes, Head of Downstream Processing at Codiak BioSciences
Some therapeutic targets have long frustrated drug developers hoping to crack the code of mitigating un…