Search results for " analyze" in Articles / App Notes
Article
Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Perhaps one of the next focus areas in product safety will be how to better analyze and control the levels of Anti A/Anti B hemagglutinins in IVIG products to avoid undesirable clinical and haematolog…
Article
Regulatory Challenges in the QbD Paradigm
Data and trends are collected and analyzed to identify any patterns or trends for specific categories of products or similar products even after drug approval. Metrics are developed to understand the …
Article
Welcome to the new Process Development Forum
August 15, 2013
Welcome to the new Bioprocess Development Forum (PDF) website.
We launched www.ProcessDevelopmentForum.com two years ago as a new channel for information relevant to research…
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QbD and PAT in Upstream and Downstream Processing
As mentioned previously, the difference lies in the fact that the samples are much cleaner and hence easier to analyze. However, the time for decision is significantly less, thus making PAT implementa…
Article
Flexibility in Biopharmaceutical Manufacturing
It is not too difficult to see how proposed flexible approaches can be analyzed for cost benefit and applied to the known unknowns, but what about the unknown unknowns? Flexibility to cover every poss…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The amount of infectious particles was analyzed by assaying 50% tissue culture infective dose (TCID50). The total amount of virus particles was determined by virus count (Virus Counter 2100, ViroCyt, …
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…