Meta Analysis of Virus Partitioning in Fractionation
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1 Meta Analysis of Virus Partitioning in Fractionation Dr. Herbert Dichtelmüller Director Virus Validation Biotest; Dreieich, Germany IPFA/PEI Meeting; Budapest; May
2 Cold Ethanol Fractionation Developed by Cohn and Oncley in 1940 to 1950 Used for separation of fractions of human plasma Essential production steps for immunoglobulins and albumin By addition of ethanol in the cold, fractions are precipitated and then separated from the supernatant 1
3 Cold Ethanol Fractionation: Example for a centrifugation process Plasma Removal of Coagulation Factors Precipitation of Fraction I Discarded Supernatant Fr I Precipitation of Fraction II/III Resusp. Fr II/III Precipitation of Fraction III disc. Supernatant Fr III Precipitation of Fraction II Resuspended Fraction II Immunoglobulins Supernatant of Fraction II/III: Albumin Precipitation of Fraction IV/IV Discarded Supernatant of Fraction IV/IV Precipitation of Fraction V Resuspended Fraction V Human Albumin 2
4 Cold Ethanol Fractionation: Example for a filtration process Plasma Removal of Coagulation Factors Precipitation of Fraction I/II/III Filtrate of Fraction I/II/III: Albumin Resusp. Fr I/II/III Precipitation of Fraction I/III disc. Filtrate Fr I/III Precipitation of Fraction II Resuspended Fraction II Immunoglobulins Precipitation of Fraction IV/IV Discarded Supernatant of Fraction IV/IV Precipitation of Fraction V Resuspended Fraction V Human Albumin 3
5 Cold Ethanol Fractionation Virus Removal: How does it work? By addition of ethanol in the cold, protein fractions are precipitated and then separated from the supernatant / filtrate Protein and viruses are precipitated together into waste fractions: Supernatants / Filtrates are virus depleted - Fractions III or I/III for immunoglobulins - Fractions II/III or I/II/III and fraction IV-1/IV-4 for albumin 4
6 BACK UP : Cold Ethanol Fractionation EMA Guideline 269 Statements on Partition Processes "...Furthermore, partition processes involve a large number of variables that are difficult to control and are difficult to scale down for validation purposes. Minor differences in physiological properties of viruses can have a major influence on partitioning..." "...it may be difficult to demonstrate that partition processes are reliably effective." "...If a partition process gives reproducible reduction of virus load and if manufacturing parameters influencing the partition can be properly defined and controlled and if the desired fraction can be reliably separated from...fraction, then it could fit the criteria of an effective step." 5
7 Companies contributing to data collection to the data collectioncompanies contributing to the data collectioncompanies contributing to the data collectcompanies contributing to the data collectionion 6
8 Data Collection: What was collected Examples Prod. Fract. Ethanol (%) Temp. ( C) ph PPT time (h) Process Filter aid Virus RF (log10) HA II/III Centr. no HIV 3.96 HA I/II/III Filtrat. yes PRV 4.66 HA IV/IV Centr. yes Reo 5.86 IgG III Centr. no BVDV 2.65 IgG I/III Filtrat. yes PPV 4.10 In total, data from 614 studies collected and evaluated 7
9 Fractions tested Product (n studies) Removal of Fraction Number of Studies evaluated Immunoglobulins (311) III 227 I/III 84 Albumin (303) II/III 58 I/II/III 22 IV 1/IV TOTAL 614 IV1/IV4 (n= 173) IV1+IV4 (n=24) IV1 (n=4) IV4 (n=22) 8
10 Fractions tested Process parameters: Mean values Precipitation of fraction Alcohol (%) Temperature ( C) ph Precipitation time (h) III I/III II/III I/II/III IV 1/IV
11 Cold Ethanol Fractionation: Viruses used Virus Model for Envelope Genome Number of studies BVDV HCV Yes RNA 99 PRV Herpes, HBV Yes DNA 89 HIV 1 HIV Yes RNA 59 SINV, WNV, VSV, EAV, SFV, HCV Yes RNA 25 PPV Parvo B19 No DNA 114 REO No dsrna 97 HAV HAV No RNA 48 MMV Parvo B19 No DNA 27 EMCV HAV No RNA 20 MEV HAV No RNA 16 CPV, B19, ERV, BEV, SV40 No RNA/DNA 21 10
12 Fractions tested Virus Removal: Number of studies evluated Fraction HIV BVDV PRV PPV MMV REO HAV EMCV MEV III I/III II/III I/II/III IV 1/IV Total Viruses of highest interest: BVDV, PRV, PPV and REO 11
13 Fractions tested: Immunoglobulins Results Virus Removal (Filtrate/Supernatant): Mean Values (log10) Fraction HIV BVDV PRV PPV MMV Reo HAV EMCV MEV III I/III
14 Fractions tested: Human Albumin Results Virus Removal (Filtrate/Supernatant): Mean Values (log10) Fraction HIV BVDV PRV PPV MMV Reo HAV EMCV MEV II/III I/II/III IV 1/IV 4* # * no results for fractions IV 1, IV 4, IV 1+IV 4 listed # CPV : 3.90 log10; n=5 13
15 Fractions tested Efficacy of Virus Removal Effective Moderate Poor not evaluated Fraction HIV BVDV PRV PPV MMV Reo HAV EMCV MEV III I/III II/III I/II/III IV 1/IV 4* 14
16 Fractions tested: Efficacy Efficacy of Virus Removal Steps: Studies with 4 log10 Removal (%) Product Immunoglobulins Albumin Step Fraction Studies evaluated Studies * with 4 log10 Studies* with < 4 log10 III I/III II/III I/II/III IV 1/IV 4** * all viruses ** no results for fractions IV 1, IV 4, IV 1+IV 4 listed 15
17 Fractions tested Efficacy of Virus Removal: Studies with 4 log10 Removal (%) Fraction HIV BVDV PRV PPV MMV Reo HAV EMCV MEV III I/III II/III I/II/III IV 1/IV 4* # * no results for fractions IV 1, IV 4, IV 1+IV 4 listed # CPV : 40% 16
18 Removal of Parvo Viruses Efficacy of Parvo Virus Removal: Studies with 4 log10 Removal (%) Fraction Canine PV Porcine PV Mouse MV III No data IV 1/IV Different model Parvo viruses show a different behaviour! Cave: Choice of model viruses for virus validation! 17
19 Influence of Process Parameters Centrifugation versus Filtration of Fraction III Plasma Removal of Coagulation Factors Precipitation of Fraction I Discarded Supernatant Fr I Precipitation of Fraction II/III Resusp. Fr II/III Precipitation of Fraction III disc. Supernatant Fr III Precipitation of Fraction II Resuspended Fraction II Immunoglobulins Supernatant of Fraction II/III: Albumin Precipitation of Fraction IV/IV Discarded Supernatant of Fraction IV/IV Precipitation of Fraction V Resuspended Fraction V Human Albumin 18
20 Influence of fractionation processes on virus removal Centrifugation versus Filtration Process Removal of fraction III: Centrifugation (n= 163) and Filtration (n=64) Process BVDV EMCV PPV All viruses Centrifugation n=15 n=12 n=45 n=163 Mean (log10) Filtration n=6 n=4 n=11 n=64 Mean (log10) Significance * p<0.05 p<0.01 p<0.01 p<0.001 * Mann&Whitney U Test Fr. III: More effective virus removal by separation of precipitates by filtration 19
21 Influence of process parameters on virus removal Removal of fraction III All Viruses Removal Ethanol conc. (%) Temperat. ( C) ph Precipit. time (h) Number of studies > 4 log10 Mean < 4 log10 values Significance p < p > 0.05 p < 0.01 p <
22 Influence of process parameters on virus removal: Fraction III Supernatant/Filtrate Significance tested for BVDV, HIV, PRV, PPV, REO, EMCV = 186 studies Removal Ethanol conc. (%) Temperat. ( C) ph Number of studies > 4 log < 4 log10 HIV Significance p < 0.01 > 0.05 > 0.05 > 4 log < 4 log10 PPV Significance p < 0.05 p < 0.05 > 0.05 > 4 log < 4 log10 BVDV Significance p > 0.05 p < 0.01 p <
23 Fraction III Supernatant/Filtrate Influence of process parameters: Linear Trend Lines 22
24 Influence of Process Parameters Fraction IV-1/IV-4 Plasma Removal of Coagulation Factors Precipitation of Fraction I Discarded Supernatant Fr I Precipitation of Fraction II/III Resusp. Fr II/III Precipitation of Fraction III disc. Supernatant Fr III Precipitation of Fraction II Resuspended Fraction II Immunoglobulins Supernatant of Fraction II/III: Albumin Precipitation of Fraction IV/IV Discarded Supernatant of Fraction IV/IV Precipitation of Fraction V Resuspended Fraction V Human Albumin 23
25 Removal Influence of Process Parameters on Virus Removal: Fraction IV-1 / IV-4 All viruses Ethanol conc. (%) Temperat. ( C) ph Precipit. time (h) Log10 all viruses > 4 log10 Mean < 4 log10 values all Stat. Significance p > 0.05 p > 0.05 p > 0.05 p > 0.05 Mann & Whitney U Test No significance! 24
26 Influence of Process Parameters on Virus Removal: Fraction IV-1 / IV-4 BVDV, PPV, REO (102 studies) Removal Ethanol conc. (%) Temperat. ( C) > 4 log10 Mean values < 4 log10 BVDV Stat. Signific. Mann&Whitney n.s BVDV < 0.01 ph BVDV < 0.05 PPV, REO n.s n.s n.s Influence of precipitation time: not significant 25
27 Influence of ph and Temperature on Removal of BVDV Fraction IV/IV 26
28 Influence of ph and Temperature on Removal of PPV Fraction IV/IV 27
29 Summary and Conclusions Cold ethanol fractionation contributes significantly to virus removal for Immunoglobulins and Human Albumin Virus removal in the magnitude of up to >4 to >5 log10 Viruses with a lower removal: BVDV and PPV Different model viruses for Parvo B19 with different removal "Minor differences in... can have a major influence on partitioning..." Cold Ethanol Fractionation alone is not sufficient for virus safety Additional steps for virus inactivation are necessary 28
30 Acknowledgements Lothar Biesert Fabrizio Fabrizzi Anna Falbo Eckhard Flechsig Albrecht Gröner Ilka von Hoegen Christoph Kempf Thomas Kreil Douglas Lee Gerhard Pölsler Nathan Roth Octapharma Kedrion Kedrion Biotest CSL Behring Plasma ProteinTherapeutics Association CSL Behring Baxter Bioscience Talecris Biotherapeutics Baxter Bioscience Talecris Biotherapeutics... and thanks to all the technicans in the labs, who diligently have performed the studies! 29
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