Manufacturing is defined as, “the production of raw materials and parts into consumer goods through labor, machines, tools, or chemical processing.” By that definition, Hope Biosciences is a bona fide manufacturing company. Our company’s focus is the manufacture of stem cell therapeutics for the clinical trials conducted by the Hope Biosciences Stem Cell Research Foundation (HBSCRF). The technicians who care for the cells each receive the job title, Stem Cell Manufacturing Technician. While technically accurate, I feel this title is easily misinterpreted. To me, the word “manufacturing” implies a mechanical or industrial process.
In reality, the stem cell manufacturing process at Hope Biosciences is the opposite of mechanical; our team of technicians can be more accurately described as caretakers of your stem cells, and every step of the process is done by hand. In very simple terms, we isolate stem cells from your adipose tissue (fat) and create a stem cell culture in a flask. We start with a small number of stem cells and culture them in our proprietary nutrient medium, allowing those stem cells to multiply into millions. At the end of the process, we can produce a therapy product containing what we believe is the most effective dose of your own stem cells, based on our core stem cell culture and banking technology.
Culturing the stem cells to therapeutic quantities is the most expensive, time-consuming, and labor-intensive step in the biomanufacturing process. Industrial-scale bioreactors are becoming commonplace in the commercial production of cell-based regenerative medicine products due to their ability to cut costs, decrease labor time, and produce significantly more cells in a single culture. In theory, this sounds great, especially for the person funding the operation. In practice, however, the use of bioreactors in large-scale stem cell production presents problems that can affect the quality of the cells harvested — thus affecting the patient’s outcomes following therapy.
Stem cells are so effective at regeneration within the body partly due to their high sensitivity to the environment they grow and live in. Precise conditions must be maintained to ensure uniform product quality and purity. Bioreactors face issues with nutrient gradients and waste removal, which can significantly impact cell characterization, altering both cell behavior and function. Additionally, shear forces within bioreactors and the difficult process of harvesting both threaten irreparable damage to the stem cells grown within.
Another issue posed by bioreactors is the potential for cross-contamination. Stem cell therapy can be allogeneic (donor cells) or autologous (the patient’s own cells), and Hope Biosciences is proud to offer several clinical trials and expanded access studies that use autologous treatments. When working with autologous therapies, it is vital to prevent cross contamination of individual cell cultures with other batches. This is easily achieved by having human stem cell caretakers prepare and care for each culture by hand. The use of bioreactors increases the risk of cross contamination and limits the number of individual cell cultures that can be grown at one time; and because of this, most stem cell production lines that utilize bioreactors offer only allogeneic treatments.
The stem cells in our bodies are responsible for repairing and healing; they regulate our immune system, maintain our body’s natural regenerative functions, and even promote circulation. The technicians at Hope Biosciences proudly work every day to ensure that your stem cells are healthy and of the highest quality. We do not use any robots, assembly lines, or industrial machines. We care for every cell, every day, by hand. We may be Manufacturing Technicians on paper, but, in practice, we are the passionate, hard-working Stem Cell Caretakers of Hope Biosciences.