Search results for "manufacturing" in Articles / App Notes
Article
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…
Article
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…
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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…
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Challenges in Analytical Method Development and Validation
BioPharm International spoke with Krumenaker, Krause, Guo, and Smith about the challenges involved in analytical method development and validation in biopharmaceutical manufacturing.
Biopharmac…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
…ta electronically using electronic product code information services (EPCIS) to capture events from manufacturing to serialization [and] capping to shipping.EPCIS can capture those key events and sha…
Article
Innovative Chromatography Resins Can Improve Purity and Quality
With ongoing efforts to increase monoclonal antibody (mAb) productivity in large-scale biomanufacturing, biomanufacturers continuously seek advancements in downstream processing technologies, with dow…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
What are some key guidelines for biopharma companies to follow?
Steven Lynn: I think, first off, it depends on where the company is manufacturing and marketing their products. From the US persp…