Q&A with Dr Jim Faed - QUESTION ONE HOW ARE THE STEM CELLS MULTIPLIED? (including what is added to them/what they’re fed with) These cells are grown in plastic flasks (polystyrene) for laboratory scale work but for production work will be grown in a large hollow fibre cassette which contains approximately 10,000 hollow fibres and provides an internal surface area of around 2 m². The nutrient fluids contain a physiological concentration of salts, buffers, amino acids, vitamins and lipids (various fats - mostly unsaturated fats and cholesterol), together with human albumin, human transferrin (to carry iron and some other metals), insulin and two growth factors. The cell culture medium is manufactured for us by a North American company that has very substantial experience in producing cell culture media. For laboratory scale work the basic cell culture medium costs $80-$100 per litre before the albumin, transferrin, insulin and growth factors are added, but for production work will cost close to $400 per litre before the protein constituents are added. The substantial increase in cost is caused by the requirement to manufacture the materials under FDA-regulated conditions called "Good Manufacturing Practices". These involve a special production facility and a lot of measurements to confirm that the required constituents and concentrations are actually present as specified. This is a standard part of medicines manufacturing requirements and is the reason why medicines cost so much.
Posted on: Sun, 04 Aug 2013 00:07:15 +0000
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