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Processing, Characterization, Quality control, Stability studies of stem Cells obtained from Human Cord Blood.
Madhuri Pawar, Legal Services, Food and Drugs Administration
Stem cell science is promising and moving forward with great potentials for cell based drug therapies.
With an objective of developing a useful reference for establishing a public cord blood stem cell banking facility in the State, optimization of methodology for processing, characterization, quality control and cryo-preservation was performed on six commercial samples of human cord blood units.
The 6 units of umbilical cord blood commercial samples were processed in a environmentally controlled clean room and further harvested for its enrichment into cord blood stem cells and finally collected into cryovials containing suitably diluted Dimethyl sulphoxide as cryoprotectant. Simultaneously, small portion of sample was collected in a separate vial for performing quality control testing. Cryovials containing product ready for cryopreservation first exposed to controlled rated freezing followed by cryopreservation by cooling, at - 196? in liquid Nitrogen.
The processed cord blood stem cell products were tested as per provisions of Schedule F, Part XII D (F) of Drugs and Cosmetics Act 1940 and Rules 1945(Addendum 2011) of India for compliance.
Stability studies was performed on 3 processed products of cord blood stem cell units at 2 different storage conditions –
I Cell viability at a temperature 4? ±2? -
• For 24 hours was found to be 95% ± 1% and
• After 7 days was found to be 80% ± 5%.
II The cell viability at a temperature 22? ±2? -
• Drastic reduction after 7 days, in survival ability that is up to 28% was found.
Inference: Although the optimum storage condition for cord blood stem cells is cryo-preservation at temperature between -196? and -150?, However, during transient storage, if the samples are kept at refrigerated condition 4? (±2?) up to 24 hours, the reduction in cell viability was observed to be 3 %.
The processing, characterization, quality control and storage of cord blood stem cells was satisfactorily done as per available technology.
Above work was undertaken during the Master of Pharmacy, was accomplished with the support and guidance of Director Pharma research, SPP School of Pharmacy and Technology Management, NMIMS University, Mumbai, India. Commissioner, Food and Drugs Administration, Mumbai, Maharashtra State, India.
Aforesaid study was submitted for deciding policies regarding stem cell based products by the office of Commissioner FDA, Maharashtra, comprising of Drugs controller and Assistant Commissioner, Food and Drugs Administration, Maharashtra State, India and was submitted to 47th meeting of Drug Consultative Committee, under the Drugs Controller of India for updation of statutory provisions.
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