TECHNICAL CONCERNS – In functional 3D models, organoids are not able to form complex vascular networks between tissues and vascular systems. This leads to a lack of nutrient and oxygen in cells as well as metabolic waste accumulation resulting in death of the structure. Organoids developed frRead more
TECHNICAL CONCERNS –
- In functional 3D models, organoids are not able to form complex vascular networks between tissues and vascular systems. This leads to a lack of nutrient and oxygen in cells as well as metabolic waste accumulation resulting in death of the structure.
- Organoids developed from the same stem cells result in different morphological structures. This is due to the fact that gene expression and protein degradation rates vary from cell to cell as well biomechanical stresses during tissue formation
- Organoids only mimic a part of the body not the whole body itself which limits researchers to tissue or organ specific functions.
ETHICAL CONCERNS –
- Organoids are mainly derived from induced Pluripotent stem cells (iPSCs) or Embryonic Stem Cells (ESC). ESCs are derived from inner mass cell of in vitro fertilized blastocysts. Their extraction from embryos raises major ethical concerns over value of human life as well as its dignity.
- Donor-derived stem cells give rise to concerns regarding their usage for reasons other than those approved by the donor. It also raises questions about whether the donors have been appropriately compensated or not.
- Brain Organoids consists of neural entities of human origin which brings concern over whether these structures have cognitive abilities and human characteristics.
- Existing research has shown that these future treatments involving organoids may be extremely expensive which can result in unequal distribution of effective treatments based on socio-economic status.
- Organoids can be used to test harmful bio weapons and their effects on human life.
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Scaling up production of biopharmaceuticals using microbial cell factories faces numerous challenges ; Yield optimization is critical, requiring genetic and metabolic engineering to enhance productivity. Maintaining product quality and consistency at larger scales demands stringent control over fermRead more
Scaling up production of biopharmaceuticals using microbial cell factories faces numerous challenges ;
- Yield optimization is critical, requiring genetic and metabolic engineering to enhance productivity. Maintaining product quality and consistency at larger scales demands stringent control over fermentation conditions and purification processes, addressing issues like contamination and variability.
- Upstream challenges include optimizing nutrient supply, oxygenation, and scaling fermentation parameters to maintain optimal growth.
- Downstream, efficient purification methods are crucial to achieve high purity and concentration of the final product.
- Cost considerations are significant, encompassing equipment, raw materials, energy, and labor costs, impacting economic feasibility.
- Regulatory compliance with GMP standards is essential, necessitating rigorous process validation and quality assurance.
- Technological limitations may require adaptation or development of scalable bioprocessing technologies.
- Managing environmental impacts and risks associated with scale-up, such as environmental footprint and supply chain disruptions, requires strategic planning.
- Overall, successful scaling involves interdisciplinary expertise in microbiology, bioprocess engineering, regulatory affairs, and economics to overcome these challenges and meet demand for biopharmaceuticals effectively.
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