Bioprocessing Application Notes & Case Studies

1. Single Cell Seeding Conditions For Improved Colony Outgrowth 1/18/2022

   Cloning efficiency (colony outgrowth) is often overlooked in the cell line development workflow relative to the single cell isolation step. However, recovery and growth of the single cells is a well-known challenging step in the process.

2. Analyze Media Without Removing Your mAb 1/18/2022

   Cell media analysis becomes challenging when faced with high concentrations of a protein. New mass spec-based analyzers offer a faster and simpler alternative.

3. Select The Best Chemically Defined CHO Media From The Start 1/18/2022

   A key aspect of process development is optimizing cell culture media. Whether media is sourced in-house or externally, it is vital to ensure consistency.

4. Combining VIPS And ATUM To Accelerate Commercial Cell Line Manufacturing 1/14/2022

   Scientists are constantly striving to develop the highest producing clones and to do it faster. We now demonstrate how this can be achieved by using only a handful of cloning plates.

5. At-Line Spent Media Analysis Is Now A Reality – Don’t Get Left Behind 1/11/2022

   Spent media analysis should no longer be a lengthy process. See how an at-line analyzer removes process bottlenecks and speeds up process development.

6. Multi-Column Capture Chromatography 1/5/2022

   Continuous capture chromatography allows for improved resin capacity, through continuous loading of multiple columns in series, reducing cost of goods. Read more about a multi-column capture (MCC) system developed and utilized for a project in this application note.

7. Designing Successful Viral Clearance Studies 12/23/2021

   Despite careful testing of starting materials and in-process intermediates, there is still a risk that a virus could enter the manufacturing process undetected. Here, we review the studies which involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step and measuring the virus remaining after the process step.

8. Scaling From Cell Factory™ Systems To An iCELLis® 500 Bioreactor Without Affecting Critical Quality Attributes 12/20/2021

   The challenge was to identify an effective, replicable, and large-scale lentiviral vector (LVV) manufacturing process to meet the growing manufacturing demand – especially for market application – without affecting critical quality attributes.

9. Optimizing A Perfusion Manufacturing Process For Commercial Production 12/20/2021

   Optimizing and scaling up a bench-scale perfusion manufacturing process requires development of validated analytics to support commercial manufacture.

10. Quality By Design The Highest-Standard Approach To Process Validation 12/20/2021

    The challenge was to develop and validate manufacturing processes for two novel molecules, one in phase 1 development and the other in phase 3.