The Platform Technology Approach to mRNA Product Development and Regulation.

mRNA-lipid nanoparticle (LNP) medicinal products can be considered a platform technology because the development process is similar for different diseases and conditions, with similar noncoding mRNA sequences and lipid nanoparticles and essentially unchanged manufacturing and analytical methods often utilised for different products. It is critical not to lose the momentum built using the platform approach during the development, regulatory approval and rollout of vaccines for SARS-CoV-2 and its variants. This review proposes a set of modifications to existing regulatory requirements for mRNA products, based on a platform perspective for quality, manufacturing, preclinical, and clinical data. For the first time, we address development and potential regulatory requirements when the mRNA sequences and LNP composition vary in different products as well. In addition, we propose considerations for self-amplifying mRNA, individualised oncology mRNA products, and mRNA therapeutics. Providing a predictable development pathway for academic and commercial groups so that they can know in detail what product characterisation and data are required to develop a dossier for regulatory submission has many potential benefits. These include: reduced development and regulatory costs; faster consumer/patient access and more agile development of products in the face of pandemics; and for rare diseases where alternatives may not exist or to increase survival and the quality of life in cancer patients. Therefore, achieving consensus around platform approaches is both urgent and important. This approach with mRNA can be a template for similar platform frameworks for other therapeutics and vaccines to enable more efficient development and regulatory review.

Mapping the distribution of DDT residues as DDE in the soils of the irrigated regions of northern New South Wales, Australia using ELISA and GIS.

An enzyme-linked immunosorbent assay (ELISA) specific for DDE [1,1-dichloro-2,2-bis(4-chlorophenyl)ethylene] has been used to map DDT [1,1,1-trichloro-2,2-bis(4-chlorophenyl)ethane)] residues in the top 10 cm of soil in three river valleys of northern New South Wales, Australia. Despite being almost 20 years since DDT was last applied for cotton growing in these areas, the relationship between sites of greatest application and current residue levels was strong. DDE concentrations in the range 0-2 ppm were found, although most the 389 soil samples examined contained less than 0.2 ppm of DDE. Although some relationship between mode of land use and current residue levels was apparent, this varied from valley to valley and may have reflected different farming practices and times of application. The study demonstrates that the combination of ELISA and geographical information system (GIS) analysis provides an effective means of displaying levels of soil contamination by a pesticide and the possible need for remediation.