Search results for "validation"
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
A similar pattern plays out in validation services. This is also a growing area of opportunity for CMOs, with validation services a more popular outsourcing activity than process development. In the 2…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Late-stage development starts with set up and validation of analytical methods and with securing reagents (8–10) for the analytical program. A broad range (50–60 variants) of different analytical tech…
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Breakthrough Drugs Raise Development and Production Challenges
Manufacturers need to decide dosage form and methods validation strategies much sooner, he said at the CMC workshop, and should “plan for the unexpected,” such as facility qualification failures and c…
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…
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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…
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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…
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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…