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Nucleic acid

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Binhui Bio has developed a one-stop nucleic acid drug technology service platform based on the exclusive uncapped, pseudo-UTP free and linear mRNA structure. The platform provides mRNA-LNP preparation services, including plasmid preparation, mRNA in vitro transcription, mRNA purification, liposome preparation, mRNA encapsulation, filling, and related quality control, etc., and can satisfy with customers' needs for R&D and scale-up production of nucleic acid drugs and vaccines.

Service

content
Transcription template preparation

Establishment of plasmid containing Escherichia coli bank

plasmid production and preparation of linearized transcription template by PCR or enzyme digestion

mRNA drug substance (DS) production

IVT in vitro transcription to produce capped or uncapped mRNA

LiCI or chromatography purification

mRNA encapsulation

Proprietary or commercial LNP

proprietary pilot-scale encapsulation equipment

PNI lab-scale. encapsulation equipment

Encapsulated mRNA drug product (DP) process

Sterilization filtration

filling isolator

automatic filling/capping

Production

Process

Service

features

Short service cycle, can be produced within 3 days

Capped or uncapped, UTP /N1mψTP, multiple choices of mRNA structures

Proprietary cationic liposomes and pilot-scale encapsulation equipment (Max Flow Rate: 15 L/h)

Stable encapsulation performance with controllable particle size at the 80-100nm, PDI <0.3, encapsulation efficiency > 90%

The quality control system settles for the standards of USP and ChP.

Nucleic Acid Product Service Manual

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