Immorna 嘉晨西海

Contract Development & Manufacturing Services

Immorna offers one-stop-shop contract development manufacturing (CDMO) services, based on our proprietary RNA and LNP platforms. Development and manufacturing using customers' unique platforms is also available after technology transfer.

Services span from sequence design, customized analytical assay development/qualification, DNA template manufacturing, mRNA/LNP production and purification, to fill-finish and QC release.

Integrated analytical and stability services support rapid transition of development programs from pre-clinical to clinical stage.

Strength in Development

Experience

Expert staff with biotech, big pharma and CDMO backgrounds
Pre-clinical and clinical development of RNA vaccines, immuno-oncology products and therapeutics
Successful IND applications with US FDA

Flexibility

Conventional (non-replicating) and self-replicating RNA platforms
Early and late stage development program support; 1 mg to 5 g RNA processing scale
LNP formulation and lyophilization capabilities
Options to utilize Immorna platforms or customer-developed processes

Speed

Typical lead time from DNA plasmid to DP fill/finish in 4 weeks
Internal capability for expedited Toxicology and GMP batch manufacturing

Strength in Manufacturing

Proprietary RNA and LNP Platforms

Highly potent RNA vectors
LNP formulations based on proprietary lipids
High quality DS and DP with CQAs monitored using qualified analytical assays
Established GMP capabilities with up to 5g RNA manufacturing scale for bulk RNA Drug Substance and formulated Drug Product

GMP Manufacturing Track Record

Over 30 Tox & GMP batches successfully manufactured and released
Multiple US FDA IND clearances received

Integrated GMP Services

Over 20,000 sf GMP facility
Master and Working Cell Bank manufacturing
Platform processes for plasmid, RNA and LNP production and purification
Comprehensive analytical panels for QC release and charaterization
Developmental and GMP stability studies

Services Offered

Proprietary conventional and self-replicating RNA and LNP platforms

Customized process development

Research grade material production

Toxicology study material manufacturing and release

Clinical trial material (CTM) manufacturing and release

GMP and developmental stability studies and testing

Customized analytical assays (both release a characterization), development and qualification

IND filing support

CDMO Services