Search results for " information"
Article
Handbook: Design of Experiments in Protein Production and Purification
The technique allows us to use a minimum number of experiments, in which we systematically vary several experimental parameters simultaneously to obtain suf cient information. Based on the obtained da…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
A risk-based approach, supplemented with laboratory studies and information from published literature, can be leveraged in the justification to reduce testing during cleaning qualification and continu…
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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…
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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…
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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…
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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 (…
Article
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…