Search results for " process"
Article
Modeling the Degradation of mAb Therapeutics
Kinetic modeling can be an effective tool for establishing product stability, offering a deeper understanding of these processes and allowing developers to mitigate the risk of product degradation dur…
Article
A Look into the Future of Biopharmaceutical Quality
The current processes used to update procedures, systems, and filings may not be able to keep pace with the rapid introduction of technological advances. I don’t think this is new. Science has always …
Article
FDA Framework Spurs Advanced Therapies
Need for new manufacturing technology
Indeed, developers of new regenerative medicines will require robust platform processes, such as automation technologies and 3-D bioreactors, to maintain cons…
Article
HTPD: Optimizing a mAb Chromatography Polishing Step
In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. High-throughput process…
Poster
Unlocking the potential for efficiency in downstream bioprocesses
Upstream processes are more efficient and product higher titers than before. With these improvements, new challenges arise. Downstream processes have to handle higher amounts of both targetprotein and…
Article
The Metrics of Quality Culture
Specifically, Title VII Section 705 of the Act states FDA “shall inspect establishments described in paragraph [1] that are engaged in the manufacture, preparation, propagation, compounding, or proces…
Article
Quality Systems Key to Lifecycle Drug Management
… over the past decade, partly due to the practice of “locking in” an applicant’s manufacturing process before it is fully optimized. Field inspection is not connected to knowledge gained from product…
Article
Biomanufacturing Outsourcing Globalization Continues
A solid majority of biologics developers indicated in the 2015 study that they will not offshore any of their process development for biomanufacturing over that period, a result that is consistent wit…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Protein aggregation can occur during all stages of the lifetime of a protein therapeutic, including expression, refolding, purification, sterilization, shipping, storage, and delivery processes (1). T…
Article
Fermentation for the Future
Drivers of new technology development in microbial fermentation are similar to those for cell-culture processes and include reducing costs, increasing efficiency/productivity, and enhancing quality, s…