Search results for " harvest" in Articles / App Notes
Article
Evolution of the Monoclonal Antibody Purification Platform
One major disadvantage of cation exchange as a capture step is the need to precondition the harvest at lower ionic content to promote binding. Though some of the new generation cation exchangers offer…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
After harvest, the cells were removed from the cell culture broth by depth filtration. In some cases, the broth was concentrated before the first chromatography step because of facility fit issues. Pr…
Article
QbD and PAT in Upstream and Downstream Processing
…anufacturing process are limited to the adventitious agent and bioburden testing of the cell-culture harvest material. This also holds for biosimilar products.
McKnight (Genentech): CQAs are de…
Article
Considerations in depth filter scale-up
The filter media thickness, pore size distribution, and adsorptive capacity make them the ‘go-to’ technology in harvest applications where a product is separated from a complex cell culture fluid.
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
In between, cells are harvested and used to seed the next scale of bioreactor. For adherent cells in FBRs, inoculum preparation will include growing cells initially in flatware and then in multi-tray …
Article
Fortem: One Film for Single-Use Bioprocessing
Single-use bags can now be found at every stage of bioprocessing: bioreactor and mixing systems, harvest and collection, purification, and liquid and powder storage and transportation. Thus, Cytiva ha…
Article
New Therapies Present Scaling Challenges
By scaling up cell production, process developers and operators must also overcome the challenges of properly scaling other aspects of the manufacturing process, such as cell harvesting, downstream pr…
Article
Best Practices for Selecting a Top-Quality Cell Line
… that are stable over extended cell-line generations and the long production cycle from vial thaw to harvest at large manufacturing scales,” she explains.
Two specific challenges, Cai continue…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
For mAb bioprocessing and viral-vector manufacturing, the equipment needed is similar, such as single-use bioreactors and standard harvest and downstream systems for clarification, tangential flow fil…