Microneedle array patch (MAP) technology is a promising new delivery technology for vaccines and pharmaceuticals, yet due to several differing and novel production methods, barriers to full-scale manufacturing exist. PATH conducted a manufacturing readiness assessment and follow-up interviews to identify both the current manufacturing readiness of the industry as well as how readiness varies by developer type and MAP type. Follow-up interviews identified barriers the industry faces in reaching full manufacturing readiness, including the perceived regulatory and investment risk of manufacturing MAPs at scale due to quality requirements and control methods, uncertain sterility requirements, lack of standard production methods (especially around dissolvable MAP drying methods), and the lack of available contract manufacturing organizations with MAP manufacturing capabilities. A Regulatory Working Group has been established to identify and address critical quality issues specific to MAP manufacturing with the aim of providing developers insight into what will be expected for MAP product approvals. Standardizing MAP production equipment and automatic, visual quality control could reduce the overall investment risk to developers and contract manufacturing organizations in pursuing pilot-scale manufacturing capabilities and ultimately lower barriers to the scale-up of full medical MAP product lines.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8724218 | PMC |
| http://dx.doi.org/10.1007/s13346-021-01076-4 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Cultivated meat microbiological safety considerations and practices.
Compr Rev Food Sci Food Saf
January 2025
School of Chemistry, Chemical Engineering and Biotechnology, Nanyang Technological University, Singapore, Singapore.
Cultivated meat, produced using cell culture technology, is an alternative to conventional meat production that avoids the risks from enteric pathogens associated with animal slaughter and processing. Cultivated meat therefore has significant theoretical microbiological safety advantages, though limited information is available to validate this. This review discusses sources and vectors of microbial contamination throughout cultivated meat production, introduces industry survey data to evaluate current industry practices for monitoring and mitigating these hazards, and highlights future research needs.
View Article and Find Full Text PDFOperative Fires: Variables Associated with Polymethylmethacrylate Flammability.
J Bone Joint Surg Am
December 2024
Jack Hughston Memorial Hospital, Phenix City, Alabama.
Background: Operative fires are rare but unforgettable events, with the potential for devastating outcomes. It is estimated that 650 operating room (OR) fires occur each year in the United States, with the use of electrocautery devices and polymethylmethacrylate (PMMA) as the primary ignition and fuel sources. There are several case reports of OR fires caused by PMMA and electrocautery in the literature, but, to our knowledge, no formal studies have been performed exposing the flammability of PMMA and how PMMA reacts to an electrocautery ignition source.
View Article and Find Full Text PDFSPA14 liposomes combining saponin with fully synthetic TLR4 agonist provide adjuvanticity to hCMV vaccine candidate.
NPJ Vaccines
December 2024
Sanofi Vaccines business unit, R&D, Marcy L'Etoile, France.
In the aim of designing and developing a novel saponin-based adjuvant system, we combined the QS21 saponin with low microgram amounts of the fully synthetic TLR4 agonist, E6020, in cholesterol-containing liposomes. The resulting adjuvant system, termed SPA14, appeared as a long-term stable and homogeneous suspension of mostly unilamellar and a few multilamellar vesicles, with an average hydrodynamic diameter of 93 nm, when formulated in citrate buffer at pH 6.0-6.
View Article and Find Full Text PDFA comparison of routine [Ga]Ga-PSMA-11 preparation using Locametz and Illuccix kits.
EJNMMI Radiopharm Chem
December 2024
Department of Medicinal Chemistry, College of Pharmacy, University of Michigan, Ann Arbor, MI, 48109, USA.
Background: Approval of Locametz and Illuccix kits for the manufacture of [Ga]Ga-PSMA-11 (gallium Ga68 gozetotide), a PET imaging agent for prostate cancer, as well as the corresponding therapeutic ([Lu]Lu-PSMA-617 Pluvicto), has led to a rapid increase in demand for [Ga]Ga-PSMA-11 PET imaging. Radiopharmaceutical manufacturers, using Ge/Ga generators, may decide to adopt Locametz and/or Illuccix kits, which requires a comparison to select the most suitable kit for day-to-day use. The objective of this article is to compare both kits and provide guidance for selecting one for routine use, as well as evaluate labeling consistency of both kits during routine production.
View Article and Find Full Text PDFUsing Passive Antibody Therapies in the Next Pandemic.
Curr Top Microbiol Immunol
December 2024
Department of Molecular Microbiology and Immunology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
The twenty-first century has witnessed seven human viral pandemics. Approximately once every three to four years over the past quarter-century, the world has experienced a new viral epidemic that expanded well beyond its original national borders to become a pandemic. The probability that another pandemic caused by a previously unknown agent will occur in the near future is thus very high and public health agencies must prioritize mechanisms for detecting their first signals.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!