Search results for "manufacturing"
Article
Real Time Continuous Microbiological Monitoring
By Claudio Denoya
Nonviable particulate and viable microbiological surveillance are used to evaluate the design and control of a current good manufacturing practice (cGMP)-manufacturing environmen…
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A Q&A with Eric Langer: CMOs Embrace New Technology
In our 13th Annual Report of Biomanufacturing, of the 21 areas of innovation tested, we found CMOs more interested in: chromatography, single-use probes and sensors, disposable chromatography, instrum…
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Downstream Processing Continues to Worry CMOs
Langer
Downstream processing continues to be a significant pain point for contract manufacturing organizations (CMOs), and downstream-fueled bottlenecks don’t appear to show any signs of abating, …
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Vaccine Development Faces Urgency and Challenges
Additional resources would help the US Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) further the development and manufacturing of new Zi…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
This complexity requires more complex manufacturing processes, according to Kate Keeping, senior director of biosimilars research with Decision Resources. With mAbs, notes Dingermann, glycostructures …
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Climate Change in Outsourcing
These developments have placed bio/pharma company revenues under further pressure and have forced continuing cuts in R&D and manufacturing. Government budget cuts also threaten support for pharmaceuti…
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Elucidating Biosimilars Characterization
… bench to launch can be a challenge, not just during the development stage but also in terms of the manufacturing process involved.
BioPharm International spoke with Jonathan Bones, principal inv…
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The Development and Application of a Monoclonal Antibody Purification Platform
After the demonstration run, this process was transferred to the pilot plant for manufacturing clinical supplies.
Early Platform Modifications
The original process was developed at Pfizer fo…
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Evaluating the Use of Continuous Chromatography
As the biopharmaceutical industry strives to demonstrate, continuous manufacturing offers the benefits of higher productivity and better product quality than traditional batch manufacturing. In additi…
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A Closer Look at Affinity Ligands
Large-scale manufacturing of a therapeutic monoclonal antibody (mAb) starts with the expression of the antibody in mammalian cells, typically CHO [Chinese hamster ovary] cells, followed by a series of…