Search results for " contamination" in Articles / App Notes
Article
Applying GMPs to the BioPharma Supply Chain
At an operational level, it is vital that biopharmaceutical production is carefully controlled within defined parameters and there is no possibility of contamination. Suppliers share a commensurate re…
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FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
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PDA's Technical Report for Biotech Cleaning Validation
Cleaning validation plays an important role in reducing the possibility of product contamination from biopharmaceutical manufacturing equipment. It demonstrates that the cleaning process adequately an…
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
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Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
Article
Report from the 12th Plasma Product Biotechnology Forum
With increased knowledge that implemented control strategies, as well as the manufacturing processes, showing no risk of prion contamination, a number of vCJD-related donor deferrals could be removed.…
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Enhancing Resins Addresses Purification Concerns
Christoph Burgstedt/Stock.Adobe.com
Enhancement of resin technology can improve the ability of chromatography to purify the growing landscape of increasingly complex biomolecu…
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Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
Article
Sanitization Opportunities for Protein A Resins
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Bacterial endospores present a challenge in bioproduction due to their resistance to common sanitization procedures using high concentrations of NaOH. Several protein-b…
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Remote Monitoring and Big Data Advance Upstream Automation
…and schedule of the automated solutions; the potential for increased process operational complexity, contamination risks, batch characterization, process integration issues; infrastructure challenges…