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 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
Case Study: 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.
In this case, capping efficiency reached over 98%
Case Study: 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:
GFP linear mRNA integrity: 97%
Circular RNA (circRNA):
Luciferase circRNA integrity (CE): 93% (left);
CD19-CAR circRNA integrity (CE): 95% (right)
Case Study: Capping/Tailing
Case Study: 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 PropertyAppearanceVisual Inspection
pHpH Meter
ContentmRNA ConcentrationUV/Ribogreen/HPLC
Integrity5‘- Capping EfficiencyHPLC/CE/LC-MS
Poly A Tail DistributionCE/HPLC
mRNA IntegrityCE/HPLC
Identity
SequencingSanger
Purity/ImpuritydsRNAELISA
IVT Residual Enzyme (Total Protein)ELISA
Residual DNA TemplateddPCR
SafetySterilityCompendial Method 
EndotoxinCompendial Method


1500 Fannie Dorsey Road Sykesville, MD 21784 USA +1 (224) 430-0311 cdmo@innoforcepharma.com
No. 376 Fengtu Street, Xiaoshan District, Hangzhou, China +86 571 8281 6679 cdmo@innoforcepharma.com
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