Search results for " validation" in Articles / App Notes
Article
Host-Cell Protein Measurement and Control
Upon qualification and validation, HCP ELISA can serve as a QC release assay for drug substance, and in-process pool testing results can guide the downstream process development (see Figure 2).
Fi…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Bonham-Carter attests that, for existing facilities looking to retrofit, the cost of new continuous/perfusion equipment is not that high, but “the real cost is adapting the facility and the validation…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Best Practices in Adopting Single-Use Systems
The adoption of single-use systems in biopharmaceutical production originated with the desire to minimize cleaning and associated validation. Before long, bioprocessors recognized the value of flexibi…
Article
Moving Biosimilars Forward in a Hesitant Market
That validation data also has to be given to FDA, and that requires more time and cost,” she says.
“When we think about what it takes to bring a biosimilar to market compared to what it takes to b…
Article
A risk based approach to sterile filtration
Process validation is required to establish scientific evidence that a process is capable of delivering an effective and safe drug consistently and reproducibly.
Download the white paper to learn …
Article
Maximum Output Starts with Optimized Upstream Processing
“The constrained supply chain for such materials is creating the need for daily management and frequent reshaping of production plans, while also accelerating the validation of dual sourcing to decrea…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
One consequence of this emphasis on speed is increased demand for more efficient development and validation of faster analytical methods. Rapid inline or online methods that can provide results within…
Article
Reimagining Affordable Biosimilars
… drugs in a systematic manner using established, robust statistical processes that allow testing and validation of clinical hypothesis. For biosimilars, factors that significantly impact affordabilit…
Article
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