Search results for " report"
Article
Ensuring Sterility in Small-Scale Production
…as defined in FDA’s aseptic processing guidance (1), the Parenteral Drug Association’s Technical Report #62 (2) on manual aseptic processing, and in EudraLex Volume 4, Annex 1 (3). In other words, th…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
According to Cytiva, the cost of a KUBio plant can be as much as 45% lower than a comparable, traditional facility
This year, Process Development Forum will continue to report on drug approvals, i…
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…
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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/…
Article
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 …