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GMP Biomanufacturing
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mRNA & Nucleic Acid

mRNA manufacturing software from IVT to LNP

Plasmid linearization, in vitro transcription, capping, purification, LNP formulation, and encapsulation QC with reagent lot genealogy across every enzyme, NTP, and lipid.

THE PROBLEM

Where legacy LIMS break down

mRNA manufacturing is an enzymatic process with a lot of expensive inputs. Polymerase, NTPs, cap analog, and four lipid lots all have to be traced to the final drug product, and a deviation in any one of them can invalidate the batch.

Formulation adds a second genealogy. The LNP is its own material with its own lots, mixing parameters, and encapsulation QC, and the mRNA lot and the lipid lots have to converge on one record.

Labbit tracks reagent genealogy through IVT, capping, and purification, records mixing and lipid ratio parameters at formulation, and captures encapsulation efficiency and particle size in-process with immediate spec evaluation.

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PRE-CONFIGURED WORKFLOWS

Workflows out of the box

Built visually in BPMN, adapted to your lab, and changed without a vendor release.

Plasmid Linearization; In Vitro Transcription (IVT); Capping & Tailing; mRNA Purification; LNP Formulation; Encapsulation & Particle QC; Fill & Frozen Storage
Targeted Amplicon Sequencing

Instruments and platforms

Instruments and platforms

Jacketed reactors; Eppendorf DASbox; Repligen TFF; Cytiva AKTA with oligo-dT; Precision NanoSystems NanoAssemblr; Knauer IJM; Malvern Zetasizer; Agilent TapeStation
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FAQ

Frequently Asked Questions

Does Labbit track reagent lot genealogy through IVT?

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Yes. Polymerase, NTP, cap analog, and enzyme lots are linked to each IVT batch, with capping and tailing efficiency results attached.

Is LNP formulation on NanoAssemblr supported?

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Yes. Lipid ratio calculation, mixing parameter capture, and formulation lot genealogy across all lipid lots are pre-configured.

How is encapsulation QC handled?

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Ribogreen encapsulation efficiency and DLS size and PDI results capture in-process and evaluate against spec immediately.

Does Labbit manage frozen chain of custody?

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Yes. Temperature genealogy through storage and shipment is tracked on the drug product lot.

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SEE IT ON YOUR ASSAYS

See your workflow running in Labbit

Bring an assay your team runs today. We’ll show you how it’s configured, executed, and reviewed.