Search results for " specification"
Article
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
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Article
Achieving Process Balance with Perfusion Bioreactors
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.
By Cynthia A. Challener
MG/Stock.Adobe.com
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Article
A Plastic Pipeline for Commercial Bioprocessing?
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
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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…
Article
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 …
Article
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…
Article
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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Article
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…
Article
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…
Article
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.