Adjuvant technology transfer hub
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1 Adjuvant technology transfer hub An example of transferring «enabling technologies» Nicolas Collin, DVM, PhD Vaccine Formulation Laboratory, University of Lausanne WH Collaborating Centre Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
2 utline The challenges of adjuvant access The Lausanne platform: context and main objectives Case study: transfer of oil-in-water emulsion technology Perspectives of the hub-model Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
3 Vaccine adjuvants Adjuvant: any substance that enhances, re-directs, and / or sustains the immune response to a co-administered antigen Essential ingredient of modern vaccines (subunit, recombinant vaccines) Adjuvants playing an increasingly important role in vaccine development Malaria: AS02 critical to the efficacy of RTS,S. Pandemic influenza: MF59, AS03, AF03 permit dose reduction HPV: AS04 permits longer duration of antibody HBV: AS04 overcomes non-response Allergy: MPL drives Th1, fewer injections needed Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
4 A new era for vaccine adjuvants Adjuvants in approved human vaccines Aluminium salts: aluminium hydroxide, aluminium phosphate il-in-water emulsions: MF59, AS03, AF03 TLR 4 agonists: MPL Adjuvant in clinical trials Saponins: QS21, Iscoms, AS01, AS02 TLR 3 agonists: poly I:C TLR 4 agonists: GLA, Eisai TLR 5 agonists: Flagellin TLR 7-8 agonists: R848, imiquimod TLR 9 agonists: CpG, IC31 Cationic liposomes Water-in-oil emulsions: Montanide ISA720, ISA51 Polysaccharides: Inulin Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
5 The problem Need of adjuvants for pandemic influenza vaccines (dosereduction), malaria vaccines, TB vaccines (cellular immunity), and for new vaccines / new concepts Limited access to adjuvants + Lack of know-how and expertise Use of inappropriate adjuvants & inappropriate use of adjuvants How to increase appropriate adjuvant use by vaccine manufacturers in low and middle income countries? Public Sector Know-how, freedom to operate, no commercial interest: A role to play in technology transfer? Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
6 Global Adjuvant Development Initiative Missions of the WH Global Adjuvant Development Initiative: 1. Supply portfolio of proven adjuvants accessible to public sector 2. Provide vaccine formulation services and training courses 3. Facilitate technology transfer of adjuvants to developing countries Jan 2010: creation of a center in Vaccine Formulation and Adjuvants at University of Lausanne, Switzerland Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
7 The challenges of adjuvant access The Lausanne platform: context and main objectives Case study: transfer of oil-in-water emulsion technology Perspectives of the hub-model Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
8 Vaccine Formulation Laboratory History 2010 Inauguration of the laboratory Hiring staff Building partnerships Buying equipment Creation of the technology transfer hub Technology transfer start Jan Standard perating Procedures Network ct Dec 0.5M grant from EC Communication 1.8M$ grant from US-HHS Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
9 Expertise gathered in the hub Knowledge management Intellectual Property Management Supply of adjuvants (generic, under MTA ) focus on mature technologies Saponins, oil-in-water, water-in-oil emulsions, mineral salts, liposomes Establishment of industrial process for adjuvant production: non-gmp Partner with GMP, training and technology transfer experience Letter of intent UNIL-NVI May 2010 Set-up of harmonization platform for adjuvant read-outs / standard reagents Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
10 The challenges of adjuvant access The Lausanne platform: context and main objectives Case study: transfer of oil-in-water emulsion technology Perspectives of the hub model Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
11 July 2010: HHS / BARDA Funding pportunity Announcement «Development and Sustainable Manufacturing of Adjuvanted Pandemic Influenza Vaccines in Developing Countries». Global vaccine capacity insufficient to cover needs in case of pandemic. Pandemic H1N1 (2009) experience:. Advance purchase agreements by industrialized countries. 8 months after pandemic : maximum of 500 M vaccine doses Partridge et al., 2010 Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
12 Which adjuvant for pandemic influenza vaccines? Pandemic influenza vaccines H5 inactivated virion: 90 µg HA (2 doses) needed for meeting registration criteria.split H5N1 virion + AlH µg Nolan et al., 2008 Moderate antigen-sparing effect of aluminium salts Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
13 il-in-water emulsions in pandemic influenza vaccines Pandemic influenza vaccines H5 inactivated virion: 90 µg HA (2 doses) needed for meeting registration criteria. Subunit H5 virion + MF µg. Split H5 virion + AS µg. Split H5 virion + AF µg MF59 TM -adjuvanted H5N3 vaccine Non-adjuvanted H5N3 vaccine GMTs SRH titers µg 15µg 30µg GMTs SRH titers µg 15µg 30µg 0 Day 0 Day 21 Day 42 0 Day 0 Day 21 Day 42 Nicholson et al Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
14 il-in-water emulsions H H 2 2 H 2 H 2 H 2 H 2 H 2 H 2 H 2 IL H 2 H 2 H H 2 2 H 2 H 2 Different from water-in-oil emulsions Appearance: milky Composition: Squalene: shark oil Surfactants Water + / - DL-α tocopherol + / - block copolymer + / - immunostimulants MF59 (Novartis), AS03 (GSK), AF03 (Sanofi-Pasteur), SE (IDRI) il-in-water emulsions vary in their composition Can be added extemporaneously: production / logistic advantage Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
15 Pros and cons of oil-in-water emulsions Pros Cheap, feasible, stable Extensive safety record (>140 M people including children) Possibility for extemporaneous combination Cons Higher incidence of mild adverse reactions Public perception of the safety of adjuvants (especially for squalene) Role of pre-existing immunity not fully understood Remarkable antigen-sparing for pandemic influenza vaccines Quick conversion of unadjuvanted seasonal vaccine capacity into adjuvanted pandemic vaccine capacity: (expected multiplication factor: 5 to 25) Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
16 Project strategy Knowledge management il-in-water emulsions suitable for pandemic influenza vaccine Intellectual Property Management Freedom to operate in Europe and in developing countries Supply of generic adjuvants or under MTA Standard perating Procedures for generic oil-in-water emulsion Establishment of industrial process for adjuvant production (non-gmp) Hardware acquisition, staff with industrial expertise Partner with cgmp, training and technology transfer experience Application with Netherlands Vaccine Institute as consultant First recipient of the technology Bio Farma, Indonesia ther DCVM provided letters of commitment / informal consent Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
17 verview of process / QC Process Quality control Release assays : Visual appearance ph Average particle size Squalene concentration Endotoxin content Bioburden
18 Timelines of the project ct 2010 Jan Nov Dec Feb Mar Apr May Jun Jul Aug Sep 2011 Kick-off meeting Bandung Homogenizer UNIL HPLC UNIL Zetasizer UNIL Microfluidizer UNIL Homogenizer BF HPLC BF Zetasizer BF Microfluidizer BF cgmp SP at UNIL (English) SAG meeting Lausanne Training at UNIL 2 weeks SAG meeting Bandung Training at Bio Farma 2 weeks cgmp SP at Bio Farma (Indonesian) Mil1 3 lots + QC Closing meeting Bandung Mil2 Preclinical plan ct 2011 Jan Nov Dec Feb Mar Apr May Jun Jul Aug Sep 2012 Preclinical study Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
19 Budget for future recipients Technology acquisition: process and QC Preclinical study $ 1.2 M $ 0.8 M Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
20 utline The challenges of adjuvant access The Lausanne platform: context and main objectives Case study: transfer of oil-in-water emulsion technology Perspectives of the hub-model Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
21 Hub-model under construction Resource optimization Adj 1 Adj 2 Adj 3 Adj 4 Harmonization Head-to-head evaluation Recipient 3 Recipient 2 Distribution Generic adjuvants or MTA Training courses Jul 2012 Jul 2013 Technology transfer Standard perating Procedures Vaccine formulation Service Recipient 1 Recipient 4 Recipient 5 Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
22 Perspectives Technology transfer to more recipients Training of National Regulatory Authorities Provide know-how on second generation adjuvants (Saponins, TLR4 ) Malaria, TB, Cancer vaccines Et 3 N (H) 2 P H NH H H NH H QS21 Technology transfer of enabling technology: MPL leads to capacity of developing several new products Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
23 Potential of the hub-model Harmonized evaluation Help in evaluating own technology / technology provided by 3 rd party Potential applications of hub-model to other enabling technologies Baculovirus production, reverse genetics, plant-based production Promotion of vaccine development self-sufficiency Innovative Research & Development Capacity in LMIC Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
24 Acknowledgements World Health rganization United States Department of Health and Human Services Developing Countries Vaccine Manufacturers Network Bio Farma European Commission University of Lausanne Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines, WH 1 December 2010
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