Need
Status: Need is Open
GSK is seeking analytical techniques for mRNA-based vaccine products that can separate full-length mRNAs from non-full-length mRNAs and quantify them. Analytical techniques or lab tests with high resolving power for mRNAs 10-18 kB long (molecular weight greater than 3-4 MDa), that can distinguish the full-length mRNA products from truncated mRNA species are welcome.
Long mRNAs are becoming increasingly important as therapeutic and prophylactic drug products. GSK uses mRNA that are 10-18kb in length for the vaccine development. The length of the construct is different for different drug products.
The long mRNAs must be manufactured and purified. These processes must be optimized to ensure that the maximum yield of full-length mRNA drug product is obtained.
GSK is seeking analytical techniques that can be used to separate and quantify the amount of full-length mRNA, and truncated variants of the mRNA. Such analytical technique will be used to characterize the drug product itself, and can also be used in process optimization experiments to provide information for each step of the manufacturing and purification process.
Large mRNA-based vaccine products have unique structural features that challenge the current RNA analytical techniques. Each drug product will have a different length, weight and structural profile. Routine separation techniques such as HPLC or CE can analyze much smaller mRNA products but lack sufficient separation power for this size of mRNA. Molecular biology-based techniques can have higher resolving power but can lack coverage of the full molecular sequence and lack the capability to quantify different mRNA species.
Analytical methods, which can be a combination of different methods, that:
Desirable, but not essential:
Possible approaches include, but are not limited to:
Current, unoptimized analytical techniques that cannot resolve large mRNAs, for example:
PCR based methods
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