Search results for " scale up" in Articles / App Notes
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
Article
Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …
Article
Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …
Article
Development of column packing methods based on pressure flow measurements
Scale-up of a chromatography process might appear as simply increasing the column diameter to accommodate for the higher quantity of material to be processed, while maintaining the same bed height …
Article
Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO.
By Jim Miller
While industry participants and observers talk about the “CMO industry,” they know that …
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
Article
Overcoming Buffer Challenges With In-Line Conditioning
Preparation and storage of the large number of buffers required for biopharmaceutical production can be a challenge, particularly in large production scale. In this application note, we show how in-…
Article
Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufact…
Article
Your Reliable Downstream Bioprocessing. Our Proven AxiChrom Columns
The goal for biopharmaceutical manufacturers is to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial …
Article
Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…