Search results for " sterile"
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
At larger scales, disposable aseptic connectors do allow for autoclaved probes to be inserted into single-use vessels in a sterile manner outside of BSCs. These solutions, however, says Mohindra, are …
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…
Article
New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
“These large-volume-liquid BPCs are used as the primary source of sterile process liquids or as a second source/back-up supply to reduce demand on the customer’s in-house capabilities and capacities,”…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
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Industry Adoption of Single-Use Systems Remains Low
Furthermore, if the bioprocess is classified as totally sterile, then vessels need to undergo an additional steam-in-place cycle, which can run another three hours or longer. The time used to prepare …
Article
Single-use Bioreactors Have Reached the Big Time
The company has also focused on developing single-use bioreactors that can interface with devices, such as cell retention devices, from different manufacturers and that contain sterile connections for…
Article
Continuous Manufacturing: A Changing Processing Paradigm
They also note that continuous capture typically requires sterile chromatography columns. “For downstream polishing steps, the infancy of multi-column chromatography systems is a limitation,” they add…
Article
Technologies and Practices Must Evolve to Meet Demand
Sampling systems, single-use systems, and sterile sampling received “poor” or “inadequate” grades from more than 19% of the respondents.
Survey participants also rated how the level of inno…
Article
Manufacturers Struggle with Breakthrough Drug Development
FDA will want to know how the company will validate manufacturing processes for drug substances and products, will ensure microbial control for sterile drugs, and will handle changes in formulation an…