Two new CEN (European Committee for Standardization) Workshops are being planned which will complement the activities of the EU Research project ETERNAL. These activities will seek to establish standardized methods for 'determining the encapsulation efficiency of RNA and DNA in LNPs using fluorometry' and 'early-stage sustainability assessment for chemical and biochemical manufacturing processes' respectively.
Find out more about what is planned below.
The encapsulation of RNA and DNA in lipid nanoparticles (LNPs) is an important emerging technology in the delivery of genetic materials for therapeutic applications. However, accurate determination of encapsulation efficiency remains challenging, and other traditional methods such as gel electrophoresis and UV spectroscopy offer present limitations.
The proposed Workshop aims to meet this need by establishing a standardized method for determining the encapsulation efficiency of RNA and DNA in LNPs using fluorometry. The approach provided by this Workshop leverages fluorescence-based detection for higher sensitivity and specificity, which offers a clear distinction between encapsulated and free nucleic acids.
The resulting CEN Workshop Agreement (CWA) will be applicable to manufacturers of lipid nanoparticles in academia and industry. The results will form a valuable basis for design for pharmaceutical and biotechnology companies. It will allow these companies to consider nucleic acid encapsulation efficiency in the early design phases and hence develop more effective and reliable delivery systems.
The kick-off meeting for the Workshop will take place remotely via Microsoft Teams on 4th June 2025 from 10.00 a.m. to 12.00 p.m. (CEST). Further details and instructions on how to attend can be found here.
It is not easy to make decisions about comparative sustainability during the early stages of chemical or biochemical process development. The quality of the data may be uncertain and multiple route options might be present for consideration. Moreover, a full life cycle assessment (LCA) typically requires a significant investment of time and resources. Sustainability is a complex topic for project teams that need to answer the question early on of “which alternatives are most likely to turn out to be the most sustainable?”. This is not helped by the lack of appropriate decision-making criteria.
A second CEN Workshop will concentrate on this problem in light of the work already done in ETERNAL by Britest to develop a Framework for Early-Stage Sustainability Assessments (FESSA) which combines the Multicriteria Decision Analysis (MCDA) tool and computed uncertainty range (CURE) calculation method. The approach supports a facilitation aid for teams seeking to make an assessment of the relative sustainability credentials of different process options at an early stage of a project (pre-LCA).
The kick-off meeting for this Workshop will be an online meeting and is planned to take place via Microsoft Teams on 19th June 2025 from 10.00 am to 12.00 pm (CEST). Full details and a registration link to attend can be found here.
A CEN ‘Workshop’ is a temporary group that develops CEN Workshop Agreements (CWAs). CWAs are essentially self-regulatory agreements developed by stakeholders for a specific area of standardization, often in emerging or rapidly changing technologies. They provide a quick and flexible mechanism for developing technical specifications or addressing the results of research projects.
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