Bioprocessing Application Notes & Case Studies

1. Advanced Formulation Development By Design In The Context Of Holistic Drug Production 4/15/2021

   A trend in drug substance and drug product biomanufacturing is increasing therapeutic complexity. Solving complex challenges calls for innovative mindsets, technological advancement, and proficient and complementary expertise.

2. Immuno-Oncology In Vitro Assays 4/12/2021

   Targeting immune checkpoints such as the PD-1 PD-L1 pathway has proven in recent years to be an effective treatment approach resulting in a range of approved mAbs that bind PD-1 or its ligand PD-L1. In this application note, we discuss our recently developed assay format to characterize checkpoint inhibitor mAbs, specifically discussing those that target the PD-1 PD-L1 pathway.

3. Capillary Isoelectric Focusing (cIEF) As A Platform Method For The Evaluation Of Monoclonal Antibody Charge Variants 4/12/2021

   The determination of charge variants of therapeutic proteins is a regulatory requirement for pharmaceutical companies. This application note demonstrates the suitability of capillary isoelectric focusing (cIEF) to assess the charge heterogeneity of different types of monoclonal antibodies. Our results prove that the developed cIEF method can be used as a platform to obtain unique profiles for different IgGs and effectively resolve their charge variants, with enough sensitivity to identify differences between the innovator and its biosimilar.

4. Impact Of A Chemically Defined Medium For Vero Cells Cultivation And Virus Production For Vaccine Applications 4/9/2021

   In the race to create serum-free, chemically defined media, research efforts have focused on identifying the elements required for superior growth performance. This include growth factors, hormones, carrier proteins, lipids, transition metals, vitamins, polyamines, and adhesion factors. This application note describes 4Cell® NutriVero™ Flex 10, a new Vero cell medium that is serum-free, chemically defined, and animal component-free. 4Cell® NutriVero™ Flex 10 delivers performance that matches conventional media with undefined hydrolysate supplementation.

5. A Multi-Scale Approach To CHO Media Benchmarking 4/9/2021

   Competitive commercial CHO processes demand a balanced combination of media, process and production clone to achieve optimal performance. The aim of this study was to apply a multi-scale approach to efficiently screen combinations of chemically defined commercial media and various CHO production clones using benchtop bioreactor systems.

6. 4Cell®BHK-21 CD Medium - Adaptation Of BHK-21 Cells To Suspension Using Chemically Defined Medium 4/9/2021

   BHK-21 cell strains have been utilized for several years as a platform for veterinary vaccines and recombinant protein manufacturing. However, these cells are anchorage-dependent, requiring the use of dissociation agents that slow and are traumatic for cells while also creating scale-up limitations. In this study, we successfully adapted anchorage serum-dependent BHK-21 cells to suspension in a chemically defined (CD), serum-free, Sartorius medium.

7. Concentrating On AAV Impurities With Ultrasensitive Total Protein Detection On Simple Western 4/6/2021

   mpurities in protein products can be dangerous and impact efficacy. For example, protein impurities in final drug products could lead to undesirable immune responses in patients, so detecting total protein is critical for revealing impurities in preparative protein production. Simple Western™ assays on instruments like Jess and Wes from ProteinSimple offer fully automated protein separation and quantification with small sample volumes, and sensitive chemiluminescent-based immunodetection and total protein detection.

8. Switch To A Nitrogen-Free Cryopreservation System 4/5/2021

   This study focuses on the running costs and carbon emissions associated with cryopreservation equipment, comparing a liquid nitrogen (LN₂)-free controlled-rate freezer with a typical liquid nitrogen-based system. The environmental implications of using liquid nitrogen for cell freezing are explored along with carbon emissions during the manufacture, transportation, and operation of LN₂-free controlled-rate freezers.

9. Bridging Anti-CHO HCP Antibodies From Two 3rd Generation Cygnus CHO HCP ELISA Kits By AAE-MS 3/26/2021

   Cygnus Technologies is transitioning the CHO HCP ELISA, 3G Kit  to the resupply version. This study is an antibody coverage comparison of polyclonal antibodies supporting the original CHO HCP ELISA Kit, 3G, F550 vs. the resupply CHO HCP ELISA Kit, 3G, F550-1

10. Cloning Of Three Cell Types Comparing The Namo™ Single Cell Dispenser To Flow Cytometry And Limited Dilution Cloning 3/23/2021

    Limiting dilution cloning (LDC) has been the standard method established for generating clonal cell lines, based on statistical data, but it is time-consuming and can be inefficient. This case study compares methods, using different cell lines, to determine which would deliver the highest number of viable clones.