Bioprocessing Application Notes & Case Studies

1. Biopharmaceutical Company Solves Storage Density Problem With Single-Use Bags 5/27/2020

   The customer, a global biopharmaceutical company with a global total turnover of > 10 billion USD, produces more than eight different bulk drug substances (BDS) in batch sizes from 100l to 1300l. The biggest problem for the customer was the growing expensive cold storage capacity due to the low storage density of bottles, based on their shapes and dimensions. learn how the customer moved to single-use bags protected by a flexible bag manufacturer independent and high storage density secondary packaging, which is designed for freezing applications to solve their problem.

2. Investigating The Important Parameters For Packing Nuvia HR-S Resin At Process Scale 5/27/2020

   Process-scale production typically involves more than one column. The packing quality of each column affects the efficiency of the whole workflow and is an important validation criterion. Here, we investigate the effects of packing methods, packing solutions, compression factor, resin slurry concentration, and bed height on the efficiency of packed columns.

3. Biopharma Realizes Advantage Of Automated Filling Of Bulk Drug Substances 5/26/2020

   A biopharma compared costs, advantages, and disadvantages of manual handling versus automated filling of bulk drug substance, prompting a switch to next-level automated drug substance handling.

4. CAR-T Cell Lentiviral Transduction By Spinoculation 5/21/2020

   There is a growing need to close and automate manufacturing of chimeric antigen receptor (CAR)-T cell therapies. CAR-T workflows depend on ex vivo gene transfer by lentiviral transduction for therapeutic efficacy. To streamline this step while keeping flexibility during process development, we introduced stand-alone SpinOculation C-Pro protocol software.

5. Liquid Retention Comparison In PC And PETG Containers 5/8/2020

   Fluid retention is an important consideration when choosing a container. The physical design and material of construction of the container impact how much fluid remains after dispensing. Fluid retention is an important consideration when choosing which container to use. This application note is a comparison between different container products.

6. Considerations For Development Of A Platform Lentivirus Harvest Clarification Process For Cell And Gene Therapy 4/27/2020

   One of the new technologies emerging in the biotech manufacturing market is the use of viral vectors for cell and gene therapy. One commonly used viral vector in this space is lentivirus, due to its robustness to package and deliver target DNA. This work explores a variety of lentivirus harvest clarification options and items for consideration during manufacturing platform development of viral therapy production using suspension cell lines.

7. Cell Culture Media Filtration: Filter Selection And Sizing 4/24/2020

   Upstream bioprocessing is evolving with improvements in cell line development and cell culture media optimization. This application note provides an overview of different filtration options in terms of microbial retention and filtration capacity and provides filter sizing recommendations for MilliporeSigma catalog media and additives. Increased understanding of these different criteria should help biomanufacturers select the right filter for their process needs.

8. Automated High Throughput mAb Purification Using Fibro Technology 4/21/2020

   Biomanufacturing is trending towards higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs below 100 kg/yr. These trends are fueling demands to screen more clones faster and improve the efficiency of process development (PD). Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.

9. Production Of Therapeutic Plasmid DNA In Single-Use Fermentors 4/17/2020

   The manufacturing of plasmid DNA is becoming a supply bottleneck due to rapidly growing demand for various gene-targeting biotherapeutics. Many producers and end users are moving towards expanding or implementing single-use production facilities to efficiently meet the demand. Here we will review three procedures for production of therapeutic plasmid DNA in single-use fermentors.

10. Purification Of Antibody Fragments, Single Domain Antibodies 4/9/2020

    This application note contains key information and recommendations regarding the affinity purification of VHH sdAbs and antibody fragments that contain a VH domain, but not an Fc region.