In the past few years, there has been a significant surge in the demand for recombinant proteins and cellular systems for biomedical research, diagnostics and different therapies. In order to support the large- scale production and manufacturing of such cell- based products, there is an imperative need for the efficient development of high- quality stable cell lines. In fact, 60-70% of manufacturing processes of available biologics require live mammalian systems.[1] A cell line refers to a defined population of cells that originates from a single common ancestor cell and have the ability to retain stable phenotypes and functions.  In general, once the primary culture is sub-cultured, it becomes a cell line.[2]

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Cell lines have revolutionized scientific RD and are currently being used for a myriad of applications.

The development and characterization of cell lines is both technically challenging and financially demanding. It requires cost intensive materials, specialized genetic engineering technologies, aseptic cell culturing conditions, specialized infrastructure for cell storage, and product-specific analytical techniques for cell / cell line testing. Recent years have witnessed the emergence of a large number of highly qualified contract research organizations (CROs), contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that assist drug developers and researchers, and offer the following benefits:

• Reduction of economic burden: Cost of developing and characterizing cell lines may vary between few thousand dollars to hundreds of thousands of dollars, depending on the cell line engineering methods, expression hosts, upstream and downstream process development and the type of tests required during research and / or the production phases. For instance, cell lines edited using CRISPR/Cas9 system are likely to be priced higher. Service providers have the potential to reduce the financial risk for the stakeholders that do not have the capacity, capability or the in-house expertise to carry out such operations.
• Enables companies to focus on research: Contract service providers offer a variety of services for different cell lines, allowing developers and researchers to avail analytical tests as per their requirements. Therefore, outsourcing cell line development and characterization operations allows product developers to focus their efforts on RD activities.
• Knowledge expertise: Service providers have the necessary skillset to carry out complicated procedures in minimum time with reduced chances of failure. In addition, these organizations often provide consulting services to assist researchers to obtain accurate results and address regulatory concerns.
• Risk Sharing: One of the crucial factors determining the net outcome of any industrial process is risk-analysis. Outsourcing few of the components of an industrial process is just like shifting certain responsibilities to the outsourced vendor. Henceforth, it is a mutual understanding between the companies to handle the risk factors in a better way.
• Integrated offerings: Nowadays, contract services providers are offering full range services, from cell line generation to screening and characterization, including the establishment and maintenance of master cell banks (MCBs) and working cell banks (WBCs), along with the end-product formation from cell lines.

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Despite the increasing opportunity in this domain, high entry costs (associated with building the required technical expertise and setting up of facilities) and rising regulatory stringencies, are the primary impediments to the number of stakeholders entering this market. For sponsors looking to outsource, there are multiple areas of concern associated with engaging service provider entities; some of the prominent challenges faced, include lack of necessary expertise for substandard cell growth troubleshooting, and process transfer related complexities. The selection of an inappropriate service provider partner can prove to be disastrous in the long run, creating issues, such as delays and cost overruns.  

Despite the aforementioned challenges, the growing demand for novel biologics, especially amidst COVID-19 pandemic, impending patent expiries of several blockbuster biologics, growing popularity of regenerative medicines and cellular vaccines, and advancements in genetic engineering and bioanalytical technologies, are some of the major factors that are anticipated to drive the growth of cell line development and characterization services market, in the mid to long term.

Key Questions Answered

• Who are the leading players offering cell line development services?
• What kind of CDMO support is available for cell line development, across different regions?
• What are the common sources, gene delivery methods, protein yield and affiliated services offered by the cell line development service providers?
• Who are the leading industry and non-industry players offering cell line characterization services?
• What are the most popular services offered for characterization of cell lines?
• Which partnership models are commonly adopted by stakeholders in this industry?
• How is the current and future opportunity likely to be distributed across key market segments?
• What are the anticipated future trends related to cell line development and characterization market?

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