Search results for " report" in Articles / App Notes
Article
The Tide Stays High
Public reports for more than 300 companies tracked by PharmSource show that R&D spending by those companies has risen every quarter since the beginning of 2015.
Not surprisingly, this has been gre…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
The good news is that, partly because of the efforts to remove or inactivate viruses, there have been no reported cases of disease transmission from a biopharmaceutical manufacturing process to a pati…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
PDA, Technical Report #71: Emerging Methods for Virus Detection. PDA 2015.
14. ICH, Q5D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used fo…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The average concentration and relative standard deviation (%RSD) were reported.
Analysis of test articles (culture media—The target concentration of glucose in the test article was used to calcula…
Article
Vaccine Development Faces Urgency and Challenges
Researchers recently reported progress in combating Middle East Respiratory Syndrome (MERS), and US investment in research to protect against bioterrorism has led to a new vaccine to treat anthrax exp…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Observations have been reported of genomic DNA mutations in the cell lines utilizing the DHFR/MTX system (24), and the mutation rates measured by 6-thioguanine (6-TG) assay positively correlated with …
Article
Innovative Therapies Require Modern Manufacturing Systems
In the process, FDA met nearly all the review timeframes and goals set by the Prescription Drug User Fee Act (PDUFA V), reported John Jenkins, director of CDER’s Office of New Drugs (OND), at the FDA/…
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Tools for Continuous Bioprocessing Development
In fact, operation in continuous perfusion culture mode has not been reported for any of the microbioreactors systems described in previous passages.
Scale-down for continuous bioprocessing
For …
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Furthermore, the GC apparatus on the front end of the mass spectrometer can identify each of the different linked structures with their different reporter groups, because these have different elution …
Article
Selecting a Comprehensive Bioburden Reduction Plan
Mittelman and Anicetti are co-chairs of the Parenteral Drug Association task force that developed the bioburden and biofilm technical report titled, PDA Technical Report No. 69, (TR 69) Bioburden and …