Considerations for mRNA Product Development, Regulation and Deployment Across the Lifecycle.

Publication date: Apr 28, 2025

With the successful deployment of several mRNA vaccines against SARS-CoV-2, an mRNA vaccine against RSV (respiratory syncytial virus) and a large pipeline of mRNA products against other infectious diseases, cancers and rare diseases, it is important to examine the whole product lifecycle. mRNA technology enables product design, testing and manufacturing systems to be rapidly developed, but these advantages can be lost if other factors that determine public access are not closely considered. This review analyzes key aspects of the mRNA product lifecycle including candidate design, manufacturing, quality systems and product safety and storage. Regulatory thinking is well advanced in some countries but not others, but more thought on the regulation of mRNA vaccines outside of a pandemic situation as well as mRNA therapeutics including individual neoantigen therapies and rare disease treatments is needed. Consumer acceptance-the “social license to operate” around mRNA products-is critical for their uptake, particularly outside of a pandemic.

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Concepts	Keywords
Cancers	lifecycle
Lifecycle	mRNA
Mrna	platform technology
Rare	regulation
Vaccines	safety
	vaccine development

Semantics

Type	Source	Name
disease	MESH	infectious diseases
disease	MESH	cancers
disease	MESH	rare diseases
disease	IDO	quality
drug	DRUGBANK	Coenzyme M
disease	IDO	production
disease	MESH	influenza
disease	MESH	melanoma
pathway	KEGG	Melanoma
drug	DRUGBANK	Spinosad
disease	IDO	nucleic acid
disease	IDO	process
disease	IDO	cell
drug	DRUGBANK	Trestolone
pathway	REACTOME	Translation
drug	DRUGBANK	Adenosine
pathway	REACTOME	Innate Immune System
drug	DRUGBANK	Natural alpha interferon
drug	DRUGBANK	Uridine
disease	IDO	protein
pathway	KEGG	Ribosome
drug	DRUGBANK	Amino acids
disease	MESH	histocompatibility
disease	MESH	COVID 19
disease	MESH	varicella
disease	MESH	zoster
disease	IDO	pathogen
disease	MESH	infection
disease	MESH	rabies
drug	DRUGBANK	Gold
disease	IDO	host
disease	IDO	infection incidence
disease	IDO	endotoxin
disease	MESH	uncertainty
drug	DRUGBANK	Sucrose
drug	DRUGBANK	Phosphate ion
disease	IDO	country
drug	DRUGBANK	Medical air
drug	DRUGBANK	Silicon dioxide
disease	MESH	Genetic Diseases
disease	MESH	metabolic diseases
disease	IDO	history
disease	MESH	hemophilia
disease	MESH	methylmalonic acidemia
disease	MESH	acute intermittent porphyria
drug	DRUGBANK	Ornithine
disease	MESH	propionic acidemia
disease	MESH	phenylketonuria
pathway	REACTOME	Phenylketonuria
disease	MESH	cystic fibrosis
disease	MESH	ornithine transcarbamylase deficiency
disease	MESH	primary ciliary dyskinesia
disease	IDO	intervention
disease	MESH	defects
pathway	REACTOME	Immune System
disease	MESH	immune tolerance
disease	MESH	recurrence
disease	MESH	lung cancer
disease	MESH	gastrointestinal cancers
disease	MESH	colorectal cancers
disease	MESH	pancreatic cancer
pathway	KEGG	Pancreatic cancer
disease	MESH	glioblastoma
disease	MESH	medulloblastoma
disease	MESH	brain tumors
disease	MESH	adenocarcinoma
drug	DRUGBANK	Atezolizumab
disease	IDO	facility
pathway	REACTOME	Metabolism
disease	IDO	site
disease	MESH	Bell’s palsy
disease	MESH	Guillain Barre syndrome
disease	MESH	pulmonary embolism
disease	MESH	stroke
disease	MESH	thrombosis
disease	MESH	thrombocytopenia
disease	MESH	lymphadenopathy
disease	MESH	appendicitis
disease	MESH	complications
disease	MESH	autoimmunity
disease	MESH	pericarditis
disease	MESH	myocarditis
disease	MESH	virus infection
drug	DRUGBANK	Testosterone
disease	MESH	smallpox
disease	MESH	anthrax
disease	MESH	causality
disease	MESH	allergic reaction
disease	MESH	erythema multiforme
disease	MESH	Heavy menstrual bleeding
disease	MESH	urticaria
disease	MESH	chronic urticaria
disease	MESH	acute disseminated encephalomyelitis
disease	MESH	transverse myelitis
disease	MESH	myelitis
disease	MESH	pancreatitis
disease	MESH	injection site reaction
drug	DRUGBANK	Pembrolizumab
disease	MESH	hypertension
disease	MESH	alopecia
disease	MESH	edema
disease	MESH	anorexia
disease	MESH	dyspnea
disease	MESH	thromboembolism
disease	MESH	anemia
disease	MESH	emergency
drug	DRUGBANK	Huperzine B
disease	MESH	measles
pathway	KEGG	Measles
disease	MESH	morbidity
disease	MESH	death
disease	MESH	vaccine preventable diseases
drug	DRUGBANK	Methionine
drug	DRUGBANK	(S)-Des-Me-Ampa
disease	IDO	algorithm
drug	DRUGBANK	Lauric Acid
drug	DRUGBANK	Rasagiline
disease	MESH	Neglected Tropical Diseases
disease	MESH	Ebola virus disease
drug	DRUGBANK	Sulfasalazine
disease	MESH	Zika virus infection
disease	MESH	vaccinia
drug	DRUGBANK	Nonoxynol-9
drug	DRUGBANK	Guanosine
disease	MESH	arginase deficiency
pathway	KEGG	Glutathione metabolism
disease	MESH	argininosuccinic aciduria
disease	MESH	Neurodevelopmental Disorders
disease	MESH	Retinal Diseases
disease	MESH	Retinitis Pigmentosa
disease	IDO	susceptibility

Original Article

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