ATMP CDMO Service

RNA Drug Substance

Advances To The Next Level of mRNA Development

The rapid advances in mRNA technology enable the introduction of any functional proteins into the human body, bringing great hope to combat a wide range of incurable diseases. Innoforce integrates innovation and accumulated experience to deliver best-in-class mRNA products and streamline the development of your mRNA therapeutics.

Best-in-class mRNA Service Provider

Innoforce brings together a world-class GMP facility, a seasoned technical team, proprietary technologies, and a well-established quality system to make the mRNA revolution possible from discovery and development to GMP manufacturing.

01 Process development

Aiming to expedite mRNA therapeutics development, Innoforce provides agile development strategies by evaluating platform process feasibility, applying a plug-and-play model, or involving a seasoned team to customize the manufacturing process.

02 GMP manufacturing

Innoforce has extensive experience in mRNA drug substance GMP manufacturing, including linear mRNA, circular RNA, and self-amplifying RNA. We have sufficient capacity to support mRNA programs scaling from 100mL up to 50L.

Technical Expertise

Capping/Tailing

At Innoforce, we developed both enzymatic capping and co-capping process to flexibly meet clients’ requirements. For both capping approaches, the capping efficiency reached over 98% applying platform process.

Capping Efficiency

Purification

Thanks to the unique plasmid manufacturing process and In Vitro Transcription (IVT) process, the existing of impurities such as dsRNA was well controlled, and it largely released the pressure in downstream purification. The purity of mRNA was proved to be high in all three platforms, linear mRNA, circular RNA and self-amplifying RNA.

Linear mRNA purity: 97%

Circular RNA Purity: Luciferase circRNA Integrity (CE): 93% (left); CD19-CAR circRNA Integrity (CE): 95% (right)

Self-amplifying RNA Purity: Before purification RNA integrity (CE) 68% (left); After Purification RNA integrity (CE): 85%

Capping/Tailing

Purification

Technical Expertise

Innoforce has established robust and reproducible analytical methods based on the current regulatory environment and clients’ needs. We can perform more than 120 analytical assays and provide clients with multiple method options to balance efficiency, compliance, and costs.

Quality Attribute

Attribute

Method

General Property	Appearance	Visual Inspection
General Property	pH	pH Meter
Content	mRNA Concentration	UV/Ribogreen/HPLC
Integrity	5’- Capping Efficiency	HPLC/CE/LC-MS
	Poly A Tail Distribution	CE/HPLC
	mRNA Integrity	CE/HPLC
Identity	Sequencing	Sanger
Purity/Impurity	ds RNA	ELISA
	IVT Residual Enzyme (Total Protein)	ELISA
	Residual DNA Template	ddPCR
Safety	Sterility	Compendial Method
Safety	Endotoxin	Compendial Method

Project Delivery Strategy

Our PD and GMP manufacturing team collaborate closely and work efficiently to provide an optimal strategy for your program.

We start with the transfer of your molecule and evaluate the fitness with platform process.

If platform process works, we simplify the process by applying plug-n-play model, and directly transfer to GMP manufacturing team for producing quality products.

If platform process does not fit with the molecule, we transfer to our PD team for trouble shooting to develop an optimal process with agility.

Technical transfer from PD team to GMP manufacturing team to produce quality products.

Resource

Download - Innoforce RNA CDMO Services

Download - Innoforce Plasmid CDMO Services