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Emerging Trends in Cell Banking (Technical Insights) : Trends in Master and Working Cell Banking

  • December 2014
  • 60 pages
  • Frost & Sullivan
Report ID: 2590444

Summary

Table of Contents

Research Scope

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.

Key Findings

Regulatory Strategy
The strategy for preparing MCBs and WCBs is clearly defined for biopharmaceuticals regulation. Strategies to be applied to cells aimed to be used strictly as part of bioanalytical test methods is unclear.

Complexity
Recombinant production cell lines represent one of the most complex starting material systems to get manufacturing licensing approval for the production of master and working cell banks.

Stem Cell Banks
Stem cell banks are gaining increasing attention and they are seen as critical resources of biological materials for both basic and translational research. Policy and governance approaches vary in different countries, becoming necessary to identify areas of convergence and variance.

Biomanufacturing
Key to success are cooperation and networks between all players in the drug development process at the entire value chain of biopharmaceutical production – from expertise in drug discovery, process and plant development, contract manufacturing, quality management to a strong service sector in the areas of registration and marketing.

Technology Process Overview

Cell banking forms a critical part of the cell line development and manufacturing process. When referring to cell banking, there are three types of cell banks, that can be prominently addressing the needs of biopharmaceutical companies. Master cell banks, working cell banks and clinical cell banks. With the present upsurge in cellular therapies, there is an increasing demand for cell banking services. The figure above, represents a typically process outline of end to end services provided by multiple contract manufacturing organizations (CMOs) in the biopharmaceutical space. Currently cell banking is one of the most outsourced services largely due to the lack of in house storage facilities, trained professionals and cryopreservation technology. It is also cost effective for a biopharmaceutical company to store their cell lines with a CMO that offer cell banking service. Cell banking services are now available in short term durations, as well as for extended periods. There are various cell bank repositories, that have also been set up for the academic and governmental utilization.

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