Search results for " report" in Articles / App Notes

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article Navigating Emerging Markets: Middle East and North Africa
In a report to the Office of the United States Trade Representative, PhRMA called out these two countries as requiring review. In Algeria, PhRMA cites weak patent protection, government-mandated price…

Article Quality by design for biotechnology products—part 1
Consequently, companies may be able to develop an efficient, cost-effective commercial process for such products, and benefit from a more flexible reporting mechanism for changes to the application af…

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