Search results for " information" in Articles / App Notes
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Automating Bioprocesses
All this additional information needs to be part of the batch record. Maintaining data integrity and traceability becomes more complex.
Another difference is in the sensors used to collect data an…
Article
Managing Risk in Raw Material Sourcing
Data transparency now the norm
Pharmaceutical manufacturers are demanding not only cGMP compliance, documentation support, and close management of critical changes, but increased information trans…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Cell- or animal-based bioassays can also be used to provide information about the complete function of a biotherapeutic drug.
Process development for chemistry, manufacturing, and controls (CMC) (…
Article
The Metrics of Quality Culture
On the surface, the questions just seem to be a regurgitation of information contained in the APR or PQR. Upon closer evaluation, however, it is clear that FDA is trying to measure whether a company d…
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Quality Systems Key to Lifecycle Drug Management
Pfizer is involved with some 24,000 postapproval changes a year for its 30,000 products, noted vice-president Roger Nosal at the April 2015 CMC Workshop sponsored by the Drug Information Association (…
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Host-Cell Protein Measurement and Control
Protein separation and visualization methods, such as 2D-SDS-PAGE, supplement HCP ELISA by providing information on individual HCP properties. 2D-SDS-PAGE with silver stain or other sensitive staining…
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Application of Quality by Design to Viral Safety
From this information, PCR- or infectivity-based assays can be developed for use in routine testing. ICH Q5A, Note for Guidance on Quality of Biotechnological Products: Viral Safety Evaluation of Biot…
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Using Quality by Design to Develop Robust Chromatographic Methods
If structures are known, then the experimental screening strategy may be supplemented by the information to be gleaned from a Log(P) vs. pH plot (P is the octanol water distribution coefficient of all…
Article
Applying GMPs to the BioPharma Supply Chain
Suppliers need to understand and apply the concept of corrective action preventive action (CAPA), and they need to be able to produce information and reports to support the paperwork trail.
Scient…