In recent years, a number of new cell and gene therapies have been developed to treat a variety of indications, including cancer and inherited retinal dystrophies. While these therapies have proven to be beneficial to patients, their scalability and manufacturability are two enduring challenges. To address the growing need for these therapies, the industry continues its pursuit of ways to improve efficiency and optimize bioproduction processes.
Technology Networks spoke to Tara St.Amand, PhD, MBA, director of business technology, bioprocess at Corning to learn more about the key challenges faced when scaling up the manufacturing of cell products. St.Amand also compares adherent- and suspension-based production and highlights how Corning is supporting the generation of advanced therapies by enabling the production of large quantities of adherent cells.
Laura Lansdowne (LL): What are some of the key challenges faced by the cell and gene therapy industry when scaling up processes to achieve commercial volumes of product?Tara St.Amand (TSA): With the rapidly growing number of clinical trials underway and planned, the industry needs scalable, cost-efficient manufacturing of cells and cell products. Recombinant adeno-associated viral (AAV) and lentiviral vectors, for example, have emerged as leading gene delivery methods for in vivo and ex vivo gene therapies, respectively. A major challenge in manufacturing adherent cells for advanced therapies is producing the large quantities of cells needed in a cost-effective manner. Space constraints often hinder large-scale bioproduction. Labor-intensive processes add time and cost to mid-to-large scale biotherapeutic production. Converting to suspension cell culture may not be a viable solution for certain cell types as product isolation in suspension cell culture can be challenging, costly and time consuming.
LL: How do adherent bioproduction processes compare to suspension manufacturing systems?TSA: Most tissue-derived cells in the body require a surface or extracellular matrix to support growth and normal proliferation. Adherent cell culture platforms provide scalable options with increasing cell growth surface areas for production and the option to utilize specialty surface chemistries and coatings that mimic a local microenvironment.
Adherent cultures also give the gift of time a significant benefit if youre racing to get a therapy to market. If you already have an adherent-based system being utilized for the development and production of other regulatory-approved therapies, and you know how to scale quickly, it might be to your benefit to stick with the same proven platforms to get through clinical trials and approvals.
Suspension methods range from small-scale vessels like Erlenmeyer and spinner flasks to large-scale stirred-tank bioreactors. At the higher end of the range, the benefits of suspension are scale and control, which makes those suspension platforms an attractive option for manufacturers looking for operational efficiency in the lab.
However, the trade-off could be more work up front, as researchers must adapt anchorage-dependent cell types to suspension environments. That takes time and effort, and anchorage-dependent cells might suffer from growth reduction and lower yields during adaptation. In addition, the shear forces and stresses that occur in suspension culture are detrimental to many cell types, but especially anchorage-dependent primary cells and stem cells.
LL: How does the Corning Ascent Fixed Bed Reactor (FBR)System work and how is it helping to improve the scale-up of adherent cells for bioproduction?TSA: The Corning Ascent FBR System is an adherent cell culture platform designed to deliver significant surface area intensification and high-yield bioproduction cost efficiently. The Ascent FBR Systems bioreactor features a specially treated and packed woven polymer mesh substrate that is designed to provide uniform fluid dynamics, even distribution of media and cells, and efficient removal of waste media. The uniform media flow and cell distribution helps to enhance cell health and productivity and achieve high yields of cells and cell-based products. Initial studies with a development controller demonstrated transfection efficiencies greater than 90% and cell harvests with yields and viability greater than 90%.
In addition, the Corning Ascent FBR benchtop system is a closed system that operates outside of a biosafety cabinet or cleanroom. Aseptic connectors allow the user to remove the bioreactor vessel for sampling inside a laminar flow hood without interrupting a run.
In 2022, Corning plans to introduce pilot and production versions of the Ascent FBR System. These will enable users to scale up from the 5 m2 bioreactor of the benchtop system through intermediate-sized bioreactors to as much as 1,000 m2 in the production system, all utilizing the same woven mesh substrate technology.
LL: Besides the bioproduction of advanced therapies, what other applications can the system be used for? TSA: The initial application focus of the Ascent FBR System is on production of viral vectors, particularly AAV and lentiviral vectors. We are actively exploring other application workflows, including stem cell expansion (hMSC, hPSC) and Vero cell production. Because of its viable cell harvest capability, the Ascent FBR System may support a wide range of workflows that require harvesting large volumes of viable cells.
Tara St.Amand, PhD, MBA, was speaking with Laura Elizabeth Lansdowne, Managing Editor for Technology Networks.
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