Drug Discovery App CS WP

61. Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions 4/13/2021

    During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand.

62. 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.

63. 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.

64. 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.

65. 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.

66. 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.

67. Liquid Nitrogen-Free Cryopreservation For Sustainability 4/5/2021

    Discover the environmental implications of using liquid nitrogen for cell freezing, along with carbon emissions during the manufacture, transportation, and operation of LN₂-free controlled-rate freezers.

68. The Science Of Cell Therapy Thawing 4/5/2021

    A summary of the science of thawing following conventional slow freezing methods, the physical and biological implications of key metrics and components, and key studies from scientific literature.

69. Biopharma Accelerates Lab Digitalization With BIOVIA One Lab 4/5/2021

    A biopharma company’s experimental records, recipes and scientific results were stored in multiple Excel files, scanned PDF documents and siloed lab solutions, many of which did not use the same conventions from lab to lab or scientist to scientist. disconnects were leading to additional lab work at late stages, workflow inefficiencies, long review times, delayed decisions, excessive effort and wasted material. They needed to implement a common solution across all CMC labs and for all therapeutic modalities—both small molecules and biologics.

70. Accelerating Discovery With Improved IP Management - Streamlining Lab Execution With BIOVIA 4/5/2021

    Inefficient lab workflows and poor visibility across research data was threatening to jeopardize clinical programs, from discovery to registration and beyond for a biotechnology company. They needed to replace their legacy, paper-based processes with an entirely digitalized lab environment that supported the innovation lifecycle from target identification to compound discovery and process development.