Custom mRNA Services
Premium Grade mRNA at an Affordable Price.
Lower cost, faster timelines, uncompromising quality.
- When your program demands precision, reliability, and clinical readiness, CELLSCRIPT™ delivers. We aren’t just manufacturers; we are pioneers in RNA biology. Building on a foundation of more than 30 years of technical expertise in mRNA synthesis, we possess the deep knowledge required to navigate complex synthesis challenges.
- CELLSCRIPT™ achieves cost savings in custom mRNA manufacturing through in‑house production of both DNA templates and recombinant enzymes to produce mRNA.
- Our state-of-the-art manufacturing facility is currently supporting partners through Phase 1 and Phase 2 clinical trials.
DNA Template Preparation
DNA templates from E. coli-derived plasmid for optimal transcription
- Our DNA template services deliver precision and reliability for mRNA production.
- Clients can provide their own plasmid and we’ll create Master and Working Cell Banks under rigorous quality control standards. Every template undergoes comprehensive QC testing before making it into mRNA synthesis, ensuring consistency and compliance at every step.
mRNA cGMP Manufacturing
Scalable, cGMP compliant RNA synthesis for your clinical needs
- CELLSCRIPT™’s cGMP manufacturing ISO7/Grade C cleanroom suites are designed for flexibility and compliance with FDA 21 CFR 211 facility requirements.
- We offer scalable in vitro transcription (IVT) reactions utilizing our in-house enzymes or your preferred vendor. Select from our various modified nucleotide options to minimize immunogenicity and enhance translation of your mRNA.
- Our downstream purification processes are optimized to remove reaction byproducts, including dsRNA, crucial for cellular performance.
QC Analytics
Comprehensive characterization ensuring identity, purity and potency
A robust analytical quality control strategy is paramount to mRNA therapeutic success. We employ a battery of state-of-the-art methods to fully characterize the drug substance and drug product.
Appendix & Resources
Available CELLSCRIPT™ Custom Services
Research Use Only (RUO): Not for use in humans or for clinical, therapeutic, or diagnostic purposes.
GMP-Grade: GMP-Grade materials are manufactured under a rigorous quality management system designed to comply with current Good Manufacturing Practice (cGMP) requirements for use as raw materials, starting materials, or ancillary materials.
Terms and Conditions: Custom mRNA services currently offered by CELLSCRIPT™ under the defined Terms & Conditions
FAQs
Q: What are your typical quality release specifications?
A: We collaborate closely with partners to tailor process conditions to meet their required CQAs. Our typical manufacturing processes are designed to achieve >95% Cap 1, ≥120 nt poly(A) tail and <0.005% dsRNA.
Q: Do you support transport of mRNA product to third party vendors?
A: We coordinate temperature controlled and temperature monitored shipment of mRNA drug substance to third party sites for downstream processing, such as final drug product formulation.
Q: Can you manufacture using raw materials from suppliers other than CELLSCRIPT™?
A: Alternative vendor raw materials can be integrated into our manufacturing workflows, provided they meet the required specifications and support regulatory expectations.
Q: What modified nucleotide options are available?
A: We offer N1-methyl-pseudouridine, pseudouridine and 5-methyl-cytidine.
Q: Is it possible to request support for just one component of the workflow?
A: We’re able to support individual components of our workflow, including standalone DNA template production or analytical services.
