Search results for " report"
Article
Improvements in Protein A Chromatography
Recently people have reported in excess of 500 cycles on protein A. While this provides great value for routine manufacturing of large quantities of mAb, the value should be balanced against the devel…
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Witnessing Major Growth in Next-Generation Antibodies
De Fougerolles expects Ablynx to report results of an on-going Phase III study in the second half of 2017 and be at the approval stage in 2018.
“There are very few limitations when it comes to the…
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Downstream Processing for Cell-Based Therapies
Addressing the DSP challenges
Table I: Overview of ultra scale-down tools reported in literature as predictive tools for several different large-scale downstream processing steps and/or processing…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
How can technology advances resolve data integrity problems?
Data integrity is a major focus of FDA; the agency routinely cites firms in warning letters for failure to accurately record, report, a…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Those may include antibody-dependent cellular toxicity (ADCC), complement-dependent cytotoxicity (CDC) assays, reporter assays, and potency assays. Technologies used typically include ELISA, electroch…
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Single-Use Extractables and Leachables: Cytiva's Alignment with the BPOG Protocol
The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious. In this environment, BPOG has published a proposal for such a standard appr…
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Biosimilars to Drive Modern Manufacturing Approaches
The Ohio Public Employees Retirement System reported at the conference that its drug program formulary has added a tier for biosimilars and generic specialty drugs, with a maximum $100 copay for the l…
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Improving Process-Scale Chromatography
While there are no approved downstream processes using continuous chromatography yet reported, according to Ljungqvist straight-through processing (STP), in which two or more chromatography steps are …
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Defining Risk Assessment of Aseptic Processes
Your management is correct to be concerned when there is a reported increase in the number of viable organisms in the environment. It is often difficult to determine where a potential microbial ingres…
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Real Time Continuous Microbiological Monitoring
It is important to emphasize that with the LIF-based monitoring instruments, the data are reported in biologic/fluorescent counts, not CFU. If a trend is observed in the air microbial sampler, however…