The execution of different test methods aiming to evaluate the stability and potency of biopharmaceutical products, as well as, their pharmacokinetic/pharmacodynamic (PK/PD) profiles, their characterization and comparison with other drugs, or the detection of antidrug antibodies (ADAs) or neutralizing antibodies (NAB), represent critical stages in drug discovery and development. On that note, cells and cell-based reagents constitute the foundations of most operational challenges. Indeed, cultured cells are frequently used to generate monoclonal antibodies (MAbs), enzymes, or substrates to be then utilized in other types of tests, such as ligand binding and enzymatic assays, thereby requiring distinct characterization and control measures to guarantee functional reliability over time.
The extreme sensitivity of cellular components to different chemical and physical elements and the possibility of alterations in the proteome expression profiles hold significant importance in assessing biopharmaceutical products. Therefore, the need for homogeneous, stable cell banks capable of safeguarding starting cellular material is substantial to perform reliable cell-based assays. Master and working cell banks (MCBs and WCBs) are established with the aim to provide a continuous source of viable cells that allow to generate accurate results for specific test methods.
This research service brings out the emerging trends in MCBs and WCBs on a global scale, through a detailed description of:
The technology capability and value chain; analysis of global technology trends.
An impact analysis of major drivers, restraints, and challenges influencing the growth of cell banks by timeframes.
An assessment of technology adoption and development, by region, demand side analysis, and recommendations for technology/product/services developers.
An evaluation of scenario modelling and emerging opportunities in MCBs and WCBs, technology management strategies and technology application roadmap.
A list of key patents of noteworthy innovations of global participants and a detailed list of key contacts in the field.