Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation

Lutton, Rebecca E. M.; Moore, Jessica; Larrañeta, Eneko; Ligett, Stephen; Woolfson, A. David; Donnelly, Ryan F.

doi:10.1007/s13346-015-0237-z

Cited by 96 publications

(59 citation statements)

References 78 publications

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“…Finally, there is a need for the development of universal acceptance criteria and Good Manufacturing Practice specifications, permitting MN characterization and subsequent commercialization. 118 This review presented the research pertaining to in vivo MN vaccines. Vaccines have been delivered via solid, coated, hollow and dissolving MNs.…”

Section: Translation Into Clinical Usementioning

confidence: 99%

The success of microneedle-mediated vaccine delivery into skin

Marshall

Sahm

Moore

2016

Human Vaccines & Immunotherapeutics

116

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Microneedles (MNs) are designed to specifically target the outermost, skin barrier layer, the stratum corneum, creating transient pathways for minimally invasive transcutaneous delivery. It is reported that MNs can facilitate delivery without stimulating the pain receptors or damaging blood vessels that lie beneath, thus being perceived as painless and associated with reduced bleeding. This immunocompetence of the skin, coupled with its ease of access, makes this organ an attractive vaccination site. The purpose of this review was to collate primary scientific literature pertaining to MN-mediated in vivo vaccination programmes. A total of 62 original research articles are presented, compiling vaccination strategies in 6 different models (mouse, rat, guinea pig, rabbit, pig, macaque and human). Vaccines tested span a wide range of viral, bacterial and protozoan pathogens and includes 7 of the 13 vaccine-preventable diseases, as defined by the WHO. This review highlights the paucity of available clinical trial data. MN-delivered vaccines have demonstrated safety and immunogenicity in pre-clinical models and boast desirable attributes such as painless administration, thermostability, dose-sparing capacity and the potential for self-administration. These advantages should contribute to enhanced global vaccine access.

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Section: Translation Into Clinical Usementioning

confidence: 99%

The success of microneedle-mediated vaccine delivery into skin

Marshall

Sahm

Moore

2016

Human Vaccines & Immunotherapeutics

116

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“…For efficacious vaccine delivery, the MPMAs must be fabricated with appropriate ingredients to ensure their sufficient hardness for skin penetration and resistance to friction encountered before or during vaccination. 81 It is reported that the MPMAs are tough enough to pierce mammalian stratum corneum when they are constructed with an optimized combination of biocompatible polymers, such as PVP and PLGA, and/or sugars, such as sucrose and trehalose, and the highly active adhesives, such as CMC-Na and starch. However, in practice, human individual variation in race, gender and even age of recipients may require much more high levels of hardness for MPMAs than the standards used in models with a limited sample size.…”

Section: Hurdles To the Development Of Mpma Vaccinesmentioning

confidence: 99%

Multifunctional particle-constituted microneedle arrays as cutaneous or mucosal vaccine adjuvant-delivery systems

Wang

et al. 2016

Human Vaccines & Immunotherapeutics

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To overcome drawbacks of current injection vaccines, such as causing needle phobia, needing health professionals for inoculation, and generating dangerous sharps wastes, researchers have designed novel vaccines that are combined with various microneedle arrays (MAs), in particular, with the multifunctional particle-constructed MAs (MPMAs). MPMAs prove able to enhance vaccine stability through incorporating vaccine ingredients in the carrier, and can be painlessly inoculated by minimally trained workers or by selfadministration, leaving behind no metal needle pollution while eliciting robust systemic and mucosal immunity to antigens, thanks to delivering vaccines to cutaneous or mucosal compartments enriched in professional antigen-presenting cells (APCs). Especially, MPMAs can be easily integrated with functional molecules fulfilling targeting vaccine delivery or controlling immune response toward a Th1 or Th2 pathway to generate desired immunity against pathogens. Herein, we introduce the latest research and development of various MPMAs which are a novel but promising vaccine adjuvant delivery system (VADS).

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“…From these clinical studies on MH influenza vaccine, it is acceptable to make conclusions that vaccination with biocompatible material-constituted MAs is promising for practical use as an easy and effective method to replace conventional injection systems. Though more trials are needed to further evaluate MH vaccines in many aspects, such as long-term safety, wide-use efficacy, the cost of MH vaccination, and the real acceptability of the novel products, the primary pilot clinical studies results in valuable information in the advancement of various MA vaccines and are beginning to open the door to clinical use of MA vaccines (Lutton et al, 2015;Marshall et al, 2016).…”

Section: Clinical Trials On Dissolvable Ma Vaccinementioning

confidence: 99%

“…However, dissolvable MAs are made of polymers and saccharides and, therefore, are relatively brittle and frail, needing sufficient protection during packaging and transporting and also requiring careful operation for vaccination. For vaccine delivery or to be an effective VADS, MAs must be fabricated with appropriate ingredients selected through formulation optimization to ensure their sufficient hardness for skin penetration and high resistance to friction (Lutton et al, 2015). In this aspect, a variety of materials and chemicals have been successfully used in combination to construct MAs that can efficiently pierce mammalian skin; however, up to now, there is still no reports on MA resistance to possible damages exerted by packaging and transportation before vaccination.…”

Section: Dissolvable Ma Versus Nondissolvable Ma For Vaccinationmentioning

confidence: 99%

“…Nowadays more and more academic and company researchers are committed to the development of MA vaccines; however, big barriers to wide vaccination with MAs still exist in several aspects (Lutton et al, 2015). First, large-scale production of the MA vaccines and, especially, MAIMs for dissolvable MAs is still confronting resource shortage and technical challenges, which may not vanish until a big input of resources and efforts converged from governments, academy, and even microelectronic and biomedical industries are devoted.…”

Section: Ma Vaccination: Barriers and Hopesmentioning

confidence: 99%

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Microneedle arrays delivery of the conventional vaccines based on nonvirulent viruses

Wang

et al. 2016

Drug Delivery

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Recently, microneedle arrays (MAs) have been developed for painless inoculation of vaccines and possess many prominent advantages, including convenience for inoculation, and exact delivery of vaccine to the exact epidermal and dermal or mucosal compartments which teem with antigen-presenting cells (APCs). Among different types of MAs, while the micro-environmental stimulus-responsive MAs represent one of the developmental trends in the field, the MAs combined with the conventional vaccines that are based on nonvirulent viruses, such as live attenuated or whole inactivated viruses, and antigen-encoding DNA viral vectors, have developed rapidly into the advanced stages, with certain products already on clinical trials. The pre- and clinical research outcomes showed that the painless MA delivery of the conventional vaccines through mammalian skin or mucosa can not only elicit robust systemic and even mucosal immunity to pathogens but also, in certain circumstances, redirect the immune response toward a specific Th1 pathway, resulting in cytotoxic T lymphocytes (CTL) to erase the cell-hidden pathogens, thanks to the robust adjuvant function of MAs exerted through damaging the contacted cells to release dangerous signals. This paper focuses on reviewing the latest research and advancements in MA delivery of the conventional vaccines that are based on nonvirulent viruses, underlining MA enhancement of the overall vaccine performance and the most advanced MA vaccine products that are relatively close to markets.

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Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation

Cited by 96 publications

References 78 publications

The success of microneedle-mediated vaccine delivery into skin

The success of microneedle-mediated vaccine delivery into skin

Multifunctional particle-constituted microneedle arrays as cutaneous or mucosal vaccine adjuvant-delivery systems

Microneedle arrays delivery of the conventional vaccines based on nonvirulent viruses

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