Research Grade RNA

// Manufacturing

Scope:

We can manufacture the following RNA types by in vitro transcription:

with sizes from about 200 to 10000 nt

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.

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.

Quality

Scalability

Flexibility

Reliability

Formulation:

Multiple API’s can be formulated with WFI in order to be further processed up to Drug Product.

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

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