Search results for " manufacturing"
Article
Using Digital Twins to Model Process Chromatography
By Jennifer Markarian
A digital twin is a model of a process that allows process development experiments to be run in silico—on a computer—rather than on actual lab or manufacturing equipment. Alt…
Article
Process Development: 2020 Reflections and 2021 Possibilities
Spotlight on Vaccines and Viral Vectors
At the forefront of many minds in 2020 going into 2021 is vaccine development and manufacturing. Among the many vaccine challenges in relation to the urgenc…
Article
Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
13, 2020, Cytiva, announced that it is investing $500 million over five years to expand its global manufacturing capacity. The company will also hire nearly 1000 personnel in key areas as part of its …
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By Claire Hill
The biopharmaceutical market continues to expand at a rapid pace and the demand for upstream manufacturing capacity, particularly for growth areas such as viral vectors, is growing …
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Leveraging Data for Better Biopharmaceutical Process Control
By Agnes Shanley
Upstream biopharmaceutical manufacturing has always depended on process measurements, because precise levels of nutrients and oxygen must be monitored closely to e…
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Bioburden Control in the Biopharmaceutical Industry
Good Practices in the Biopharmaceutical Industry
Because bio/pharmaceutical products are generally intended for ill populations, bioburden control throughout the whole manufacturing plant should b…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Important manufacturing CQAs related to protein integrity, homogeneity, presence of host-cell proteins, host-cell DNA, and/or substances released from process or package material, can be identified us…
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Biomanufacturing Outsourcing Globalization Continues
Langer
BioPharm International
Volume 28, Issue 5
Biopharmaceutical manufacturing clusters continue to emerge outside of the traditional hubs of North America and Western Europe. Contract m…
Article
New Era for Generic Drugs
CDER also is working hard to cut the massive backlog of some 5000 generic-drug manufacturing supplements. An efficient supplement review process is key to encouraging product modernization and quality…
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Global Expansion Shapes Drug Oversight
Sklamberg’s GO organizes a range of capacity building programs and collaborative activities designed to strengthen regulatory systems in developing countries and to explain US and international manufa…