Search results for " pharmaceutical" in Articles / App Notes
Article
State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
• When asked a new question about what broader pharmaceutical industry small-molecule experience could benefit the biopharmaceutical industry, the leading three responses were "Process control, real-t…
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The Challenge of Disruptive Technologies in Bioprocessing
Challenges to disruptive technologies
A significant challenge to the adoption of disruptive technologies is the conservative attitude of the pharmaceutical industry itself. “This is related to the…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
Do you agree?
The plasma fractionation industry has often been regarded as a curiosity or an anachronism of the much larger pharmaceutical and biopharmaceutical industries, but this perception d…
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Making the Move to Continuous Chromatography
Additionally, they will be able to construct smaller production sites due to the reduction of skids and columns required to produce a given number of batches of a particular pharmaceutical product,” h…
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Modern Manufacturing Key to More Effective Vaccines
A report from the Pharmaceutical Research and Manufacturers of America (PhRMA) in late 2017 lists 264 vaccines in development, including 137 for infectious diseases and more than 100 for cancer (1). A…
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FDA Framework Spurs Advanced Therapies
As a further requirement of the Cures Act, FDA is working with the National Institute of Standards and Technology (NIST), members of academia, and the pharmaceutical industry to develop standards for …
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Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
One such toxin is cereulide secreted by Bacillus cereus, a ubiquitous spore former that is of concern during the manufacture of pharmaceuticals.
This work demonstrates the clearance of cere…
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Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
In a draft guidance for industry, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base (December 2015), the agency outlined a process for biopharmaceutica…