Search results for " report"
Article
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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Design and Qualification of Single-Use Systems
• Documentation should also be considered as part of product design, to include support data for performance claims, design and production validation data reports, operation guides, and other informat…
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Antibody Production in Microbial Hosts
Several aglycosylated antibodies are under clinical trials and to date, no immunogenicity issues have been reported. Tolerx (MA, USA) has developed a series of humanized aglycosylated antibodies (TRX1…
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Biopharma in 2015: A Year for Approvals and Innovations
This year, PDF will continue to report on drug approvals, innovations and industry trends that interest our readers. In the meantime, if you didn’t catch these stories the first time around, be sure t…
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Biomanufacturing Outsourcing Globalization Continues
…n the United States and Europe, according to preliminary data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1).
As part of the…
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Continuous Manufacturing: A Changing Processing Paradigm
Langer also writes that, based on data from his yearly report, “there has been no distinct trend for bioprocessing professionals to select perfusion over fed batch” (1). Even so, because perfusion inv…
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High-Throughput Process Development in an Historical Environment
Some of the remaining challenges in the upstream area were reported to be high-throughput metabolic analytics.
On the subject of formulation, David Smithson from Genentech presented how the compan…
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Application of Quality by Design to Viral Safety
Porcine circovirus (1), murine minute virus (2), Cache Valley virus (3,4), and reovirus type 2 (4) are only a few incidences of contamination that have been reported as a result of impure raw material…
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Biopharma Outsourcing Activities Update
BioPlan Associates,11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, Preliminary data (Rockville, Md., April 2014).
About the Author
Eric Langer is pres…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Both the Parenteral Drug Association (PDA) Technical Report 60 (7) and the International Society for Pharmaceutical Engineering (ISPE) Product Quality Lifecycle Initiative (PQLI) guide series (8-10) p…