Etherna Manufacturing

// Manufacturing

Research Grade RNA

Scope:

We can produce any RNA that can be produced with and in vitro transcription reaction such as:

This includes sizes from around 200 to above 10000 nucleotides.

The RNA can be made by using regular or modified NTP’s, and with different cap-analogs (CAP1, CAP0).

Quantity Ranges:

from 100 µg to gram scale and depend on the processing requirements

Processing possibilities upstream:

Different options are available with regards to purification of the linearized pDNA, the in-vitro transcription with co-transcriptional capping and poly-adenylation, or enzymatical capping and/or poly-adenylation. We can also offer a screening of different conditions to get to the optimal ones for your construct. 

Processing possibilities downstream:

Different options are available for purification including precipitation, dsRNA reduction, column chromatography, tangential flow filtration, bioburden reduction filtration, depending on the need and can be formulated in WFI or a buffer. Selection criteria depend on your use and quality requirements. 

Formulation:

Multiple API’s can be formulated with WFI in order to be further processed up to Drug Product or can alternatively be formulated in Lipid Nanoparticles (LNPs).

 

Fill-finish:

For API, filling is typically done aseptically in 50 ml tubes, AT-Closed vials or through a closed system in sterile bags. For IMP, filling is typically done in 2 ml AT-Closed vials, which are filled aseptically in a semi-automated way.

Release:

Research grade materials are released by the issue of a Certificate of Analysis
The products offered as research grade material are not for use in humans. The use of the products is under the sole responsibility of the customer

Inventory Items

Research Grade RNA specifications

depending on customer requirements and use

Download Our Buyer's Guide to GMP Grade RNA


Download Our Buyer's Guide to Research Grade RNA