// Manufacturing

GMP Grade RNA

Scope:

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

  • mRNA
  • Long RNA
  • Guide RNA

with sizes from about 200 to 10000 nt

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

Processing possibilities upstream:

Different options are available regarding the 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 like precipitation, dsRNA reduction, column chromatography, tangential flow filtration, bioburden reduction or sterile filtration, … depending on the need.

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:

The GMP batch release is done in different steps, as required by cGMP. If and when the batch can be released, this is formalized in the Certificate of Analysis and the Certificate of conformity signed off by our Qualified Person

GMP Grade RNA specifications

depending on customer requirements and use

  • Visual inspection
  • Appearance
  • Integrity
  • Identity
  • pDNA content
  • Protein content
  • Endotoxin content
  • Concentration
  • Potency
  • Sterility
  • RNA sequence

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