New Vaccine Delivery Technologies
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1 Photo: PATH New Vaccine Delivery Technologies 6 th Annual CUGH Conference Mobilizing Research for Global Health Boston, USA Darin Zehrung dzehrung@path.org Senior Technical Officer and Portfolio Leader, Delivery Technologies Vaccine and Pharmaceutical Technologies Group March 26, 2015
2 All photos: PATH New Vaccine Delivery Technologies Delivery devices Packaging Formulation Disposable-syringe jet injectors* Intradermal delivery devices* Microneedles* Intranasal delivery Aerosol/dry powder inhalation Prefilled syringes/ compact prefilled autodisable devices* Blow-Fill-Seal / multimonodose* Integrated reconstitution* Fast dissolving tablets and gels Solid-dose implants Electroporation * - discussed in presentation
3 All photos: PATH New Vaccine Delivery Technologies Delivery devices Packaging Formulation Disposable-syringe jet injectors* Intradermal delivery devices* Microneedles* Intranasal delivery Aerosol/dry powder inhalation Prefilled syringes/ compact prefilled autodisable devices* Blow-Fill-Seal / multimonodose* Integrated reconstitution* Fast dissolving tablets and gels Solid-dose implants Electroporation * - discussed in presentation
4 Photos: PATH Photo: Georgia Tech New and Alternative Delivery Technologies Many new technologies are needlefree. Some are compatible with existing vaccine formats (e.g., vials or ampoules). Others are integrated with formulation (e.g., combination products). Improved ease of vaccine delivery, efficacy, cost-effectiveness, and safety are areas of focus. Developers include industry, academic, and nonprofit research groups. Photo: The Hindu
5 Graphic: PATH Photo: WHO Potential Public Health Benefits Increase vaccine access and coverage enable community health workers to deliver vaccines. Improve immunogenicity. Reduce the need for and the number of injections. Reduce risk of infections/crosscontamination. Reduce potentially dangerous sharps waste.
6 Photo: PATH/Debra Kristensen Photo: PATH/Debra Kristensen Photo: PATH\Ümit Kartoglu Potential Public Health Benefits Relieve tensions and fears surrounding immunization. Reduce drop-out by optimizing schedules. Reduce health worker workload simplified administration and reconstitution (free up time for other tasks). Reduce cold chain dependency through improved thermostability (heat and freeze stability) incorporation of enhanced formulation in presentation.
7 Photo: WHO Photo: WHO Photo: PATH Current Challenges to Vaccine Delivery Training and availability for health care workers. Resource availability for routine, supplementary immunization activity, and outbreak response. Appropriate vaccine management and cold chain capacity. Supply access (e.g., needles and syringes, safety boxes). Needlestick injuries to health care workers. Disposal of sharps waste community needlestick injuries.
8 Disposable Syringe Jet Injectors Photo: PharmaJet. Photo: PATH. Photo: PATH.
9 All photos\bioject Delivery Using Jet Injectors Disposable Syringe Jet Injectors (DSJIs) deliver vaccines and medicines without using needles; instead, DSJIs generate a pressurized liquid stream that penetrates through the skin to deliver injections into the tissue. PATH A PharmaJet DSJI injection in action. ID injection with a DSJI. SC injection with a DSJI. IM injection with a DSJI.
10 Photo: PATH. DSJI WHO Prequalification Prequalification requirements are based upon the International Organization for Standardization standard for jet injectors (ISO+). Requires device clearance through globally recognized national regulatory authority. PharmaJet Stratis technology was the first DSJI to complete this process (January 2013).
11 All photos except where noted\path Photo/Georgia Institute of Technology Intradermal Delivery Device Categories Needle-based devices (standard needle and syringe, hollow microneedles, mini-needles, ID adapters) Disposable-syringe jet injectors Microneedle patches Field filled or prefilled with liquid vaccine
12 Graphics: PATH Intradermal Delivery Most vaccines are delivered via intramuscular or subcutaneous routes (0.5 ml). Fractional dose intradermal (ID) delivery holds potential due to the presence of Dendritic Cells (DCs) in the skin. ID vaccine examples: Rabies post exposure prophylaxis (PEP). Influenza Fluzone ID. IPV Global Polio Eradication Initiative (GPEI) research.
13 All photos except where noted\path Photo/Star Syringe Photo\BD ID Delivery Devices: Needle-based Manufacturer West Pharmaceutical Services, Inc. (West) BD Device Development Status Image ID Adapter Commercialized A Soluvia Commercialized (influenza vaccine) Star Syringe, Ltd. Star ID Preclinical C NanoPass MicronJet 600 Commercialized D B B A C D
14 All photos/path ID Delivery Devices: Disposable Syringe Jet Injectors Manufacturer Device Development Status (for ID delivery) Image PharmaJet Tropis Clinical A ID Pen Clinical B Bioject Zetajet Clinical Biojector 2000 Device clearance D Medical International Technologies(MIT) Dart Preclinical C H4 Preclinical D
15 Images: PATH Comparison of Microneedle Delivery Platforms Solid, coated, dissolving, hollow, and hydrogel. Step one: Microneedles are applied. Step two: Pharmaceutical is released.
16 Photo/Georgia Tech Photo/Corium Photo/Vaxxas ID Delivery Devices: Microneedle Patches Developer Device Development Status Patch type Components Image Georgia Institute of Technology (Georgia Tech) Preclinical Dissolvable Patch (potentially no applicator needed) A Corium MicroCor Preclinical Dissolvable Patch and integrated applicator B Vaxxas / University of Queensland Nanopatch Preclinical Solid coated Patch and applicator C A B C
17 Parenteral Prefill Technologies Manufacturer Device Development Status Image BD Uniject Market available A BD Hypak Market available B Gerresheimer Gx RTF Market available C Taisei Kako Co., Ltd ClearJect (COC polymer) Market available D Rommelag BFS for injection In development E Angela Brevetti Secureject Market available F A C E D A B C F
18 Parenteral Prefill Technologies: Uniject Uniject is a compact pre-filled autodisable device ** Photos: PATH Photos: Crucell *Uniject is a trademark of BD. **PATH website. Available at:
19 Photo: PATH\Patrick McKern All images: Rommelag (except where noted) Blow-fill-seal (BFS) Technology: Plastic containers formed, filled, and sealed in a continuous process. Equipment manufacturers: Rommelag, Weiler Engineering, Angela Brevetti. Widely used for pharmaceuticals; determined to be technically compatible with live attenuated influenza and rotavirus vaccines.
20 Photos: PATH\Patrick McKern Photo: PATH/Greg Kachmarik Oral Prefill Technologies Manufacturer Device Development Status Image BD Uniject DP Market available A BFS Market available B Rommelag BFS MMD In development C Lameplast Tube Market available D A B C D PATH 3D-printed prototype.
21 Graphics: PATH Photo: PATH/Greg Kachmarik Photo: PATH Technology example: Multi-mono-dose Multi-mono-dose (MMD): A conjoined strip of singledose containers with a single label and Vaccine Vial Monitor (VVM). Separating a single container from the strip opens the container. Formed using BFS or other plastic container technologies. Conjoined BFS packaging. CAD models of multi-mono-dose design. PATH 3D-printed prototype.
22 Photo: Lyogo Reconstitution Technologies Manufacturer Device Development Status Image Vetter Lyo-Ject Market available A Eulysis SVS In development B LyoGo LyoGo In development C LyoTip LyoTip In development D C A Photo: Vetter. B D Photo: Eulysis. Photo: LyoTip.
23 Key Considerations Vaccine Delivery Technologies Integrate new technology early in vaccine development process. Ensure alignment with generic Preferred Product Profile (gppp) for vaccines pursue consultation with WHO. Confirm programmatic suitability for WHO prequalification. Estimate device costs (cost of goods, cost per delivered dose). Assess potential cold chain impact. Confirm human factors/healthcare worker usability.
24 Thank you Darin Zehrung Senior Technical Officer Portfolio Leader, Delivery Technologies Vaccine and Pharmaceutical Technologies Group Page 24 PATH/Mike Wang
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