11.1 Study Methodology
11.1.1 We performed a comprehensive search to find all firms worldwide that manufacture RNA on a contract basis. To follow the same logic as our clinical trial analysis, we included CDMOs that chemically synthesize small RNAs such as miRNA, siRNA, ASOs and aptamers along with the CMDOs that perform IVT to produce mRNA. Because the manufacturing process is so different for the two modalities, firms rarely do both. Manufacture of the delivery methods (LNPs) are more commonly found among both types of suppliers.
11.1.2 Chemically synthesized RNAs are not manufactured in a vessel, and so discussions of scale are not in volumes, but usually in millimoles or milligrams. A 2 mole order of chemically synthesized RNA is enormous and can only be performed at the very largest firms. To our knowledge, Bachem, Agilent, and Avecia are the only firms large enough to handle this scale of chemically synthesized RNA.
11.1.3 Likewise, mRNA manufacturing is not usually discussed in terms of volume of the upstream vessel and is discussed in terms of grams. On average, a 1 L IVT vessel can produce about 1 g of material. Orders for 100 mL GMP IVT production are common and 1 L is a big batch. Even COVID-19 scale production was 50 L upstream. The purification scale, however, is much larger and uses columns and skids on roughly the same scale as pDNA or protein purification batches.
11.1.4 For this reason, we found that most firms do not list upstream scale on their websites. Although many profiles included here state the scale or capacity is unknown, one can reasonably assume the firms listed here can all perform 100 mL to 1 L IVT, or produce several mmol of chemically synthesized RNA. We’ve noted the ones that specifically perform large scale batches.
11.1.5 To create this report, we reached out to every single firm listed in this profile section. We spoke with some on numerous occasions to create the rest of the report, but many were simply contacted by us with a request to confirm the profile presented here. The firms that returned our request are noted with the company verified check mark.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.