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).
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.
Multiple API’s can be formulated with WFI in order to be further processed up to Drug Product.
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.
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
depending on customer requirements and use
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