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Tomo Yokomizo, Morikazu Miura

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Presentation on theme: "Tomo Yokomizo, Morikazu Miura"— Presentation transcript:

1 Tomo Yokomizo, Morikazu Miura
Asahi Combination Filter, Sepacell PrimaTM for Prion and Leukocyte Reduction Asahi Kasei Medical Tomo Yokomizo, Morikazu Miura 29th October, 2010

2 Asahi Kasei Medical One of major suppliers of LR filter
Many types of LR filter, used all over the world Nano-filtration technology for virus removal in plasma fractionation, etc.

3 Contents - Sepacell PrimaTM - Concept and Technology
Development Status Prion Reduction Western blot method Bioassay test Leukocyte Reduction RCC Quality Biological Safety Next Step

4 Concept and Technology

5 Simultaneous reduction of prions and leukocytes
The Concept of Filter One Step Filter Simultaneous reduction of prions and leukocytes Reducing prions from RCC Covering current LR filter functions No Additional Operating Time No Impact on Customer SOP No Further RCC loss

6 Key Points of Technology
RCC Filter SAGM Materials Base fibers: Polyester Surface: New material Prion reduction mechanism Adsorption: High affinity to prion Filter design Equivalent to the current Red Cell filter in Europe, Sepacell® Pure RC.

7 Development Status

8 Scheme of Prion Spiking Test
Scrapie infected hamster with 263k scrapie strain Brain homogenate LR SAG-M RCC Microsomal fraction (10w/v%) Filter Leukoreduced RCC used to eliminate phagocytic effect Western blot

9 Prion Spiking Test Results (1)
Prion reduction confirmed at two different test sites Sterilization tolerance to both Steam and E-Beam Test laboratories X Y Filter Pool 1 Pool 2 Pool 3 Pool 4 Log10 Reduction Factor A > 3.0 > 4.5 B - C D 0.5 0.2 A: Sepacell PrimaTM sterilized with Steam B: Sepacell PrimaTM sterilized with E-Beam C: Sepacell PrimaTM sterilized with Steam twice D: Control (Pall WBF2) Vox Sanguinis 2008; 95 (suppl. 1): 271, P-588

10 Prion Spiking Test Results (2)
No impact observed within plasma protein variation of RCC No negative effect induced by leukocytes observed (at the laboratory Y) Filter RCC Added FFP (mL) Plasma Protein (mg/mL) Log10 Reduction Facotr Control (Pure RC) LR-RCC 3.2 0.92 Sepacell PrimaTM > 4.5 9.5 7.2 22 10.8 NLR-RCC - LR-RCC: Leukocyte reduced RCC, pooled and split before FFP addition NLR-RCC: Non - leukocyte reduced RCC Transfusion 2008; 48 (suppl.): 86A, SP141

11 Scheme of Bioassay Test
Filter Microsomal fraction (10w/v%) Scrapie infected hamster with 263k scrapie strain Brain homogenate Leukoreduced RCC used to eliminate phagocytic effect Dilution series from pre / post filtration samples 0.05 mL injected intracerebrally to Golden Syrian hamsters Observed up to 365 days LR SAG-M RCC

12 Bioassay Test Results Prion reduction performance supported by Bioassay test After 365 day observation Log(ID50) reduction is 4.20 Log10 based on Spearman-Kärber method. -Log10ID50 = Log10 starting dilution – ([∑p – 0.5] x Log10 dilution factor) No abnormal or unexpected observation in the groups of; Positive control (263k microsomal post nuclear fraction) Sham injected control (HBSS) Uninjected control Vox Sanguinis 2009; 97 (suppl. 1): 101, P-092

13 LR Filter Performance (1)
Ambient Temp. Hold, Day1 Filtration Residual Leukocytes (Log WBC/unit) Sepacell PrimaTM Control (Pure RC) * No significant difference Hemoglobin (g/unit) Sepacell PrimaTM Control (Pure RC) * No significant difference

14 LR Filter Performance (2)
4 Degree Hold, Day2 Filtration Residual Leukocytes (Log WBC/unit) Sepacell PrimaTM Control (Pure RC) * No significant difference Hemoglobin (g/unit) Sepacell PrimaTM Control (Pure RC) * No significant difference Transfusion Medicine 2008; 18 (suppl.): 30, P08

15 RCC Quality Parameters evaluated Tested at day 0, 21 and 42
Hemolysis (%) C3a (ng/mL) Pottasium (mmol/L) pH Lactate (mg/dL) 2,3 – DPG (mmol/L) ATP (micro-mol/dL) Glucose (mg/dL) Tested at day 0, 21 and 42 Sample (Sepacell PrimaTM, n=9) Control (Pure RC, n=3) The results were comparable between sample and control in all the test

16 Hemolysis results Met CE guideline
Transfusion Medicine 2008; 18 (suppl.): 30, P08

17 Biological Safety Test Results
ISO 10993 Test Item EB Steam Cytotoxicity Pass Sensitization Intracutaneous Reactivity Systemic Toxicity (acute) Haemolysis Testing Ames Test with New Polymer negative Overall results show the sufficient safety of new filter. Vox Sanguinis 2008; 95 (suppl. 1): 271, P-588

18 Summary * C3a, Pottasium, pH, Lactate, 2,3-DPG, ATP, Glucose

19 Next step

20 Next step Sepacell PrimaTM to be CE marked in SCD kit
Ready to provide samples for in-vitro test To be ready for clinical test soon Asahi in-house tests are on-going Quality control method established

21 Thank you for your attention!

22 Back up pages

23 Prion Reduction Test Spiking Study by Western Blot and Bioassay test
Facility: Laboratories in Europe and US Materials Agent: The hamster 263K strain of scrapie Spiking materials: Microsomal Fraction Medium: Leukoreduced* SAGM-RCC * to avoid the possibility of WBC related removal of PrPSC, such as phagocytic effect and non-specific binding.

24 RCC Quality Test Results
Comparable RCC quality to control filter Transfusion Medicine 2008; 18 (suppl.): 30, P08


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