Column chromatography for the development of pandemic and seasonal influenza vaccines
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1 Column chromatography for the development of pandemic and seasonal influenza vaccines Olga Chervyakova Research Institute for Biological Safety Problems, RK ME&S 5 th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers Belgrade, Serbia, March 2012
2 Influenza virus purification process 2 Clarification by Filtration (2.0/1.2 µm) Ultrafiltration & Diafiltration (cut-off kd) Virus concentration (10-50 x), >90% protein removal Size-exclusion chromatography (Sepharose CL-6B) Load: not exceeding 25% of column volume Virus is eluted in the void volume
3 3 Influenza Vaccine Pandemic H1N1 H5N1 Seasonal H1N1, H3N2 B
4 Pandemic influenza vaccines: Development and Research 4 Development process Kazfluvac recombinant strain A/AstanaRG/6:2/2009 (H5N1), produced by reverse genetics at RIBSP Refluvac recombinant strain NIBRG-121 xp (H1N1), produced by reverse genetics at NIBSC Production of antigens Inoculation into the day old fertilized eggs Harvest and inactivation (formalin, 3 days) Purification& Filtration Clarification by Filtration (2.0/1.2 µm) Ultrafiltration & Diafiltration (cut-off 100 kd) Size-exclusion chromatography (Sepharose CL-6B) Microfiltration (0.22 µm) Formulation (adjuvant addition) Filling Packaging
5 Pandemic influenza vaccines: Development and Research 5 Single harvest Bulk Specifications: H1N1 Items Qualifying standards Batch Results 2009/1 2009/2 2009/3 Identity wt-like Confirm Confirm Confirm Bulk HA Content Sterility Ovalbumin Total Protein Endotoxin (EU/ml) to meet requirement Confirm Confirm Confirm fold HA content <50 <50 <50
6 Pandemic influenza vaccines: Development and Research 6 Single harvest Bulk Specifications : H5N1 Items Qualifying standards Batch Results 2009/1 2009/2 2009/3 Identity wt-like Confirm Confirm Confirm Bulk HA Content Sterility Ovalbumin Total Protein Endotoxin (EU/ml) to meet requirement Confirm Confirm Confirm fold HA content <50 <50 <50
7 Pandemic influenza vaccines: Development and Research 7 Production of pilot vaccine batches Vaccine HA content (µg/dose) Quantity (dose) Kazfluvac (H5N1) Refluvac (H1N1)
8 Pandemic influenza vaccines: Development and Research 8 Quality control of pilot vaccine batches Items Qualifying standards Kazfluvac (H5N1) Refluvac (H1N1) 2010/1 2010/2 2010/3 2010/1 2010/2 2010/3 Identity wt-like Confirm Confirm Confirm Confirm Confirm Confirm Appearance Suspension with loose sediment Confirm Confirm Confirm Confirm Confirm Confirm Sterility To meet requirement Confirm Confirm Confirm Confirm Confirm Confirm ph Pyrogenicity apyrogenic Confirm Confirm Confirm Confirm Confirm Confirm Toxicity To meet requirement Confirm Confirm Confirm Confirm Confirm Confirm Thiomersal 100± Al +3 ion (mg/ml) 1.0± Formaldehyde (%) Immunogenicity To meet requirement Confirm Confirm Confirm Confirm Confirm Confirm
9 Pandemic influenza vaccines: Development and Research 9 Phase I/II clinical trials: Kazfluvac H5N1 I.I.Mechnikov Research Institute of Vaccines and Sera, RF RAMS (Moscow) Research Institute of Influenza, NWB, RF RAMS (St.Petersburg) Phase Investigational vaccine Volunteers* Vaccine group Control Number of persons with protective antibody titers (>1:40) After 1 st vaccination (%) After 2 nd vaccination (%) I II 7.5 µg/dose µg/dose µg/dose 40 - ** µg/dose *Ages of Volunteers: yrs ** not examined
10 Pandemic influenza vaccines: Development and Research 10 Phase I/II clinical trials: Refluvac H1N1 Research Institute of Influenza, NWB of RAMS, Russian Federation, St.Petersburg Phase I II Investigational vaccine Volunteers* Vaccine group Control Number of persons with protective antibody titers (>1:40) (%) 3.75 µg/dose µg/dose µg/dose µg/dose µg/dose *Ages of Volunteers: yrs
11 Pandemic influenza vaccines: Development and Research 11 Phase I/II clinical trials: conclusion Results of clinical trials show that Kazfluvac(H5N1) and Refluvac(H1N1) are well tolerated, low reactogenic, safe and meet European СРМР ЕМЕА requirements on immunogenicity of inactivated influenza vaccines. On the basis of the results of the clinical trials applications for governmental registration of vaccines Refluvac (3.75 µg/dose ) for influenza A/H1N1v protection of the population aged between years and Kazfluvac (7.5 µg/dose ) as an influenza A/H5N1 prophylactic means were filed.
12 12 Influenza Vaccine Pandemic H1N1 H5N1 Seasonal H1N1, H3N2 B
13 Seasonal influenza vaccines: Development and Research 13 Optimization of purification conditions: NIBRG-121 xp (inactivated virus) Step Harvest/pooling Inactivation Clarification (2.0/1.2 µm) Ultrafiltration/diafiltration (cut-off 100 kd) Batch / / /3 Protein removal (%) HA total (SRID) (%) Gel-filtration (Sepharose CL-6B) Protein removal (%) HA total (SRID) (%) Detergent treatment/removal 0.22 µm filtration HA total (SRID) (%) Ovalbumin (µg/ml)
14 Seasonal influenza vaccines: Development and Research 14 Optimization of purification conditions: NIBRG-121xp (native virus) Step Harvest/pooling Clarification (2.0/1.2 µm) Ultrafiltration/diafiltration (cut-off 300 kd) Batch / / / / / /9 Protein removal (%) HA total (SRID) (%) Gel-filtration (Sepharose CL-6B) Protein removal (%) HA total (SRID) (%) Inactivation Detergent treatment/removal 0.22 µm filtration HA total (SRID) (%) Ovalbumin (µg/ml)
15 Seasonal influenza vaccines: Development and Research 15 Bulk Specifications : H1N1 Items Qualifying standards Batch Results 2012/1 2012/2 2012/3 2012/4 Identity wt-like Confirm Confirm Confirm Confirm Total Protein HA Content Endotoxin (EU/ml) Ovalbumin 6-fold HA content Sterility To meet requirement Confirm Confirm Confirm Confirm
16 Seasonal influenza vaccines: Development and Research 16 Conclusion Tangential diafiltration in combination with column chromatography may be successfully used for influenza virus purification. The method is suitable for different influenza virus subtypes. In dialysis and chromatography the same buffers are used regardless of the virus subtype. Chromatographic profiles of the different influenza virus subtypes are identical. Virus is eluted in the void volume. 99.0% removal of protein; ovalbumin content <2 µg/ml; HA yields > 30%
17 Thank you for your attention! 17
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The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.