Usually, I write about improving OpEx (operational excellence) via business process improvement. But improving efficiency of technical processes is equally vital for the OpEx mission. In this post, I shall briefly touch upon challenges in stem cell research and its manufacturing; these challenges must be surpassed to improve gains.
To start off, stem cells are cells with the potential to develop into many different types of cells in the body. To put it in layperson's language, stem cells serve as a repair system for the body. Therapies involving stem cells are hence known as regenerative medicine therapies.
In case you want to know more about what stem cells are and what do they do, I’ve a separate post covering this topic; you may check it out here.
So, let’s begin with some of the challenges to overcome with stem cell research and manufacturing …
1. Unregulated stem cell research-
Stem cell regenerative medicine therapies are expected to be beneficial for patient having spinal cord injuries, type 1 diabetes, Parkinson's disease, amyotrophic lateral sclerosis, Alzheimer's disease, heart disease, stroke, burns, cancer and osteoarthritis.
Cord blood and cord tissue stem cells have the special quality of being the purest and youngest tissue-specific stem cells you can collect and function more quickly and effectively than adult stem cells from other sources.
Stem cell research has been extremely intense since the early 2000s, with many clinical trials underway. Efforts have been hampered by regulatory uncertainties and inconsistent controls.
In recent years, stem cell research has become a truly global endeavor. Fundamental research is critical for creating a solid foundation for clinical studies. To meet these challenges, scientists in various countries (where laws permit) could work together.
While research on stem cells has spurred investment, industry development, and media coverage, there are very few clinical applications. While some companies are developing treatments with hematopoietic stem cells, they are not regulated and are not suitable for all patients. Moreover, the lack of evidence in these therapies is a significant challenge for legitimate scientists in the field and for regulatory agencies attempting to protect their constituents.
Note: Stem cells work is illegal in several countries across the globe. Hence, I’ll recommend that companies planning on initiating projects involving stem cells must first update themselves on applicable laws around stem cells in order to ensure full legal compliance.
2. Unregulated stem cell biomanufacturing-
The current situation in the field of stem cell research and manufacturing is a concern for patients. Despite some progress in recent years, there are still significant challenges to overcome before stem cell therapies are widely available. One major challenge is ‘scale-up’ or the process of manufacturing cells in large enough quantities to treat a large number of patients.
There are various sources of stem cells- From brain, bone marrow, blood and blood vessels, skeletal muscles and liver; though blood is the most applied source for stem cell collection.
Stem cells from blood are collected with an apheresis machine. Blood flows from a vein through the catheter into the apheresis machine, which separates the stem cells from the rest of the blood and then returns the blood to the patient's body.
From non-blood sources, stem cell treatments are mostly produced in petri dishes and are usually used to treat one or two patients. To help people with serious health conditions, the stem cell community will need to develop strategies for producing cells at a large scale.
Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the 'hematopoietic' system) but they are not approved for other uses.
Regulatory control of stem cell production is vital to ensure that the cells are safe and effective. Although many clinical trials are ongoing to investigate the effectiveness of stem cell therapies, this industry is still far from being fully regulated. Many unregulated clinics operate with minimal controls and risk of harm to patients.
The atrocious part is that, unregulated stem cell biomanufacturing challenges have led to unproven therapies and stem cell tourism.
3. Epigenetic analysis of stem cells-
To further explore the multipotency of stem cells, epigenetic analysis is important. Epigenetic modification occurs when chromatin is modified to regulate gene expression. For example, H3K4me3 and H3K27ac are both known to regulate gene expression. However, epigenetic modifications can also be reverted.
Recent studies have shown that the behavior of stem cells is influenced by the expression of certain chromatin remodeling factors. These factors regulate the behavior of stem cell subsets during homeostasis of compartments in adulthood. For example, certain types of stem cells can differentiate in different ways and maintain a high-level of functional fitness.
Several epigenetic players interact with transcription factors to regulate stem cell homeostasis. For example, the transcription factor p63 is required for epidermal stemness and differentiation. This transcription factor regulates genes such as the cell cycle proteins and early epidermal differentiation markers. Another epigenetic factor that regulates p63 is Setd8, which is necessary for monomethylation of lysine 20 in histone H4. When Setd8 is deleted, p63 expression is impaired and the stratified epidermis fails to form.
4. Automated process for tracking and documenting blood products-
Automated process for tracking and documenting the processing of blood products is essential for safe patient care. Records must be kept concurrently with each significant step of the blood processing process, including entry dates, person performing work, and complete history of work performed. Using a secure electronic solution, companies can store all their compliance records in one place. The process is also vital for reporting any known adverse reactions to blood products.
Automated blood supply management software can make the process easier and safer by preventing errors and ensuring a safe and reliable blood supply. It can be set up to automatically track blood products and perform cross-matching to identify incompatible blood products. This can significantly reduce the risk of mistakes or wasteful product.
5. Scale-up of stem cell manufacturing-
A successful scale-up of stem cell manufacturing process is crucial for ensuring the quality and integrity of the cells. In order to achieve this, the process must be able to control cell surface and physicochemical parameters, minimize change in cell surface, and be highly reproducible. Moreover, it must meet cGMP standards.
One solution is the use of a multiplate bioreactor. This device has a flat surface and can be used to grow and differentiate pluripotent stem cells at high production scales. The multiplate design can be used in the early stages of development as well as in the industrialization of cell therapies. However, future technological developments will be required to make the process more efficient and scalable.
Another solution is to use microcarriers and single-use bioreactors. This method allows for easy scalability and high control of product quality. It also reduces labor costs and contamination risks.
Disclaimer: Information presented here is for educational purpose only. Stem cell research, manufacturing thru commercialization is illegal in several countries across the world. Ensure that you are fully complying to the laws before undertaking any activity and/or therapies involving stem cells.
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Categories: Life Sciences | Operational Excellence
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