Search results for " drug"
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
At the 2017 meeting, the session, “Case studies Drug Substance and Drug Product Formulations” chaired by Aaron Noyes from Codiak BioSciences, contained several talks showing good progress in the area.…
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Single-use Bioreactors Have Reached the Big Time
Whereas the first disposable bioreactors were ‘plastic’ copies of their stainless-steel counterparts, new generations are redesigned while keeping the end-user, their processes, and their final drug p…
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Ensuring the Biological Integrity of Raw Materials
Contamination of biologic drugs and vaccines by adventitious agents is extremely rare. However, when contamination incidents do occur, they can be costly in terms of time and resources.
In 2010, E…
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Advancing Single-Use Technology Through Collaboration
The validity of this approach can be confirmed by leachables studies on the finished drug substance produced by the intended process, which would be indicative of the cumulative impact of all SUS in t…
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Improving Process-Scale Chromatography
…and accounts for a significant portion of downstream processing efforts (time and cost) for biologic drug substances. There is, therefore, constant pressure to improve productivity and efficiency. Ad…
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A Q&A with Eric Langer: CMOs Embrace New Technology
Contract manufacturers more readily adopt new technologies compared to drug companies that manufacture in-house. In what areas are CMOs taking the lead?
CMOs indicate a significantly greater int…
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Biosimilars: Making the Switch Comes with Challenges
With approximately 20 new biosimilars authorized for marketing across the EU since 2006, prescribing of the drugs is increasing at a rate of 11% a year, similar to the worldwide growth rate, according…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Figure 1 shows an example of a production process from cell culture to bulk drug substance.
Figure 1: An example of a production process from cell culture to bulk drug substance. Figure is courtes…
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Platform Approach Speeds Process Development
Cell-culture process development
Development of an efficient, robust, and reproducible cell-culture process is key for successful market supply of a biologic drug. Depending on project requirement…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Giner-Casares
Cell culture is widely employed in biomedical applications and has numerous applications, spanning from diagnosis, therapy, and the production of biological drugs. Cells used for bio…