It's estimated that an individual will require stem cells for a therapy at some point in life is 1 in 217. Read about how the cell banking industry is coming up with niche and specific services for cell line development and cell banking in this Frost & Sullivan analysis.
Willem Halffman and Serge Horbach from Radboud University in Nijmegen, Netherlands, published a study this month in the PLoS One journal stating that more than 32,000 scientific papers published between 1955 and the present day reported on studies that used contaminated cell lines. They called these studies “contaminated literature” that were in turn cited in at least half a million other papers. This meta-analysis of published literature observed that the impact of “contamination” varied from only marginally affecting the study results to rendering the study completely meaningless.
The Worldwide Network for Blood and Marrow Transplantation (WBMT), a non-governmental organization that comprises 19 member organizations in 70 countries, estimates that every year 50,000 patients are treated for various diseases through stem cell therapies. These include lethal but common diseases such as leukemia, sickle cell anemia and lymphoma, and rare diseases such as thalassemia, myelodysplastic syndrome and other inherited immune-deficiency metabolic disorders. The WBMT estimates that the probability that an individual will require stem cells for a therapy at some point in life is 1 in 217.
All Roads Lead to Cell Banks
The two scenarios described above are set within the healthcare industry, but on different planes. The first talks about the need for transparency and reliability in sourcing cell lines for research, while the second talks about the need for a readily available spread of stem cells for therapeutic use. The common thread is the need for reliable cell banking. Cell banks, as the name suggests, are facilities that store cells of specific genomes complete with cell line characterization and operate in a way that minimizes contamination. These banks also reduce the costs and effort associated with cell culturing and sourcing—greatly benefiting pharmaceutical companies that are reeling from mounting development costs. As a result, biopharmaceutical companies are increasingly partnering with contract manufacturing and research organizations (CMOs and CROs) to store their proprietary cell lines and develop new ones. With increased collaborations, CMOs are coming up with niche and specific services for cell line development and cell banking.
The Cell Banking Ecosystem: Cell Line Development, Storing and Testing
Three crucial steps are involved in creating a repository of cells that can be tapped into at any time, with reasonable certainty of their origins, characteristics and purity. Exhibit 1 presents an overview of the cell banking ecosystem. Exhibit 2 shows the size and the projected growth of the cell banking market.
Exhibit 2: Cell Banking Market: Revenue Forecast, Global, 2015–2020
Compound Annual Growth Rate = 16.7%
Cell lines can be broadly classified as mammalian, insect, avian or microbial based on the species from which they have been sourced. Stem cells and virus seeds are also harvested and cultured. The most commonly banked cell lines are:
Technology Framework: Emerging Trends in Cell Line Development
Several technologies contribute to the cell line development and cell banking processes.
Perfusion technology: This enables cell culture for a longer time by feeding fresh media and removing spent media using either membranes or centrifuge.
Single-use technology: There has been a notable shift from multiple-use stainless steel cryovessels to freezable plastic bags. This provides flexibility and enables easy shifts in portfolios based on market needs. It also requires less facility space, equipment and infrastructure for banking.
Cryopreservation technology: Biopharmaceutical companies are focusing on improving the quality of freezing mediums to assist and improve cell safety. This is achieved by developing cell cryopreservation protocol with controlled-rate thawing (controlled cooling and thawing rates).
Improved upstream and downstream processes: Significant process improvement is brought about by ensuring antibiotic-free production of cell lines and by introducing novel process ingredients such as chemically defined serum-free media.
Innovation Landscape: Designer Mammalian Cell Lines and Innovative Production Platforms
The introduction of designer mammalian cells lines and better culturing practices has resulted in improved cell line yield and stability. Notable products in this space are:
SURE Technology Platform from Selexis SA (Switzerland)
Selexis’s SURE platform is designed to improve the speed of mammalian cell cultures. The SURE platform accelerates the development of expression pools to as little as 3 weeks, and the development of expression clones to 12 weeks. The platform improves the yield of mammalian cell cultures 20-fold; it can yield as many as 250 stable pools of CHO cells within 5 weeks. Finally, the stability of the recombinant clonal cell lines is increased to more than 90 days.
GPEx Technology from Catalent Biologics (Madison, Wis.)
The GPEx platform uses a retrovector technology that can create stable transduction of targeted cells with a high degree of efficiency without the use of any special selectable markers. The versatile platform is widely used for mammalian cell development and protein screening across single- and multi-genetic expression applications. The GPEx platform enables the creation of master cell banks within 15 weeks, and has demonstrated the stability of a cell line for more than 100 generations.
The Road Ahead
Umbilical cord banking has become popular, with a number of private and public agencies supporting and enabling the practice of collecting and cryopreserving blood from a newborn’s cord. The idea behind this practice is that if the child were to develop a condition later in life that would require stem cells for treatment, they would be readily available. The importance of banking them becomes apparent when one realizes that ethnic matching of cells is of vital importance.
While the efficacy of therapies may be uncertain now, one can be sure that in the years to come the therapies themselves will be perfected. What is required now is preparation for that certainty.
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