Unlocking the full potential of viral-vector based therapies requires an understanding of existing challenges in viral vector production and which technologies are now available in upstream and downstream processing to help address them.

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.

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.

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.

How do you find the initial capital and attract new investors to hit your milestones and stay solvent? Experts share their experiences and offer advice for companies on the path towards bringing a potentially life-changing therapy to patients.

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.

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.

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.

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.

This guide summarizes the science of thawing following conventional, slow freezing methods. We address how cell thawing has historically developed into the techniques used today, along with the physical and biological implications of key metrics and components, such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies.