GMP-Grade Raw Materials for mRNA Manufacturing
The success of mRNA vaccines and therapeutics depends on the quality, consistency, and scalability of the raw materials used throughout the manufacturing process.
Yeasen provides a portfolio of GMP-grade molecular biology raw materials for key steps in mRNA production, supported by the ZymeEditor™ enzyme engineering platform, high-density fermentation, and UCF.ME™ ultra-clean purification technology.
From R&D and process development to commercial production, Yeasen provides reliable raw materials and quality documentation to support your mRNA manufacturing workflow.
mRNA IVTSolution (Two-Step Enzymatic Capping)
LZCap™ One-Pot Co-Transcriptional Capping
Quality & Regulatory Support
Selected Yeasen products have completed DMF filing and are supported by relevant quality and regulatory documentation to facilitate customer qualification and regulatory submissions.
Available documentation may include COA, animal-origin statements, quality and manufacturing information, and DMF-related documentation.
For authorized use of DMF registration numbers, please contact marketing@yeasen.com to request a DMF authorization letter.
Why Choose Yeasen GMP-Grade Raw Materials?
|
Quality & Compliance |
RUO-Grade |
GMP-Grade |
|
Animal-derived components |
May be present |
Animal-origin-free |
|
Cell bank characterization |
Basic |
Comprehensive characterization |
|
Raw material traceability |
Limited |
Full traceability |
|
Endotoxin control |
Limited |
Controlled to applicable pharmacopeial standards |
|
Antibiotics |
May be present |
Antibiotic-free |
|
Process validation |
Basic |
GMP-aligned process validation |
|
Change control |
Basic |
Formal change-control process |
|
Quality system |
Internal system |
ISO 13485 |
|
Regulatory documentation |
COA |
COA + supporting documentation |
|
DMF |
Not available |
Available for selected products |
