Search results for " downstream" in Articles / App Notes
Article
A New Paradigm in Process Development
Accelerate biologic manufacturing of mAbs, vaccines, and novel biotherapies. Download this e-book for case studies and insights from Janssen, Roivant Sciences, and mAbxience.
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Article
Best Practices for Selecting a Top-Quality Cell Line
byproduct impurities, which requires early downstream involvement to determine the types of impurities that are easy to remove, and consequently influences clone selection.
An experienced team is …
Article
A Successful First Year for Testa Center
The bioprocess pilot-scale facility in Uppsala, Sweden, has hosted 15 national and international projects and more than 2000 study visits since its opening in 2018.
Testa Center, a not-for-prof…
Article
Getting it Right from the Start in the Drug Development Process
Both upstream processing and downstream processing can affect critical quality attributes of the drug molecule under development. These effects can result in process-related impurities, product impuri…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Upstream, the most important CQAs include glucose concentration and cell mobility; downstream, they include turbidity, pH, and conductivity. In addition, virus, microbe, and endotoxin monitoring and c…
Article
Automating the Biomanufacturing Process
Automation implementation
For more than 15 years, biopharmaceutical manufacturers have been implementing automation and control systems, both upstream and downstream, says Christoph Lebl, head of …
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Second, scalable fermentation and downstream processing procedures were developed for each enzyme. These processes avoided the direct use of animal-derived components. Additionally, multiple productio…
Article
Biopharma Seeks Balance
…itoring and closed loop bioreactor control, next-generation sequencing, continuous manufacturing for downstream processes, and a manufacturing platform for continuous bioprocesses (2).
N…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Cell-culture media has been known to significantly impact cell culture performance, downstream processing, as well as product quality (1, 3). While substantial progress has been achieved in this field…
Article
Being Thorough When Transferring Technology
CMC Biologics has an approach where we run six 2000L SUBs in parallel, then harvest and combine the product streams downstream to produce a single drug substance lot, with an equivalent amount of prod…