mRNA

GMP regulations developed by the International Conference for Harmonization (ICH), Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S) and regional regulatory agencies such as FDA (US), EMA (European Union), and CDE (China) are written to assure the identity, strength, quality, and purity of drug products. The key considerations include factory design, process controls, quality assurance, and risk management. Porton Advanced's two GMP manufacturing facilities comply with FDA CFR title 21 and ATMP regulations. During the scale-up process, we ensure consistency in manufacturing parameters and process residues.  At the New Drug Application (NDA) stage, we conduct cleaning verification for equipment and reusable consumables. For single-use consumables in direct contact with the drug product, we test their compatibility and leachability. Additionally, to ensure robust processes, we perform process validation.

There are two main capping methods: post-translational capping and co-transcriptional capping. Both methods have been effectively utilized in approved drugs. Post-translational capping involves additional purification, buffer exchange, and enzymatic steps, making it a more complex process that can be difficult to control. In contrast, co-transcriptional capping is simpler and quicker but incurs higher costs due to the use of patented technology. It is highly recommended to use the co-transcription capping method, where in-vitro transcription and capping reactions occur in a single step. This approach involves fewer processing steps and therefore reduces costs.

Porton Advanced offers microbial strains and plasmid templates specifically designed for mRNA, which reduces plasmid polymerization and stabilizes Poly(A) tails. During process development, we will evaluate microbial strains to identify those that perform better, ultimately achieving high-quality and stable plasmid templates. 

Porton Advanced doesn't have its own proprietary LNP formulations or purchase any licenses for LNP formulations. If clients utilize LNP formulations or raw materials that require a license, they must obtain that license from the licensor themselves. However, Porton Advanced collaborates with several partners to offer our clients access to proprietary LNP formulations at a reduced licensing fee.

For investigator-initiated trials (IITs), we can deliver investigational products within eight weeks. For IND projects, we can deliver the first toxicology batch within four months and IND CMC materials within eight months.

We currently provide IVT and encapsulated mRNA products that include Luciferase, EGFP, mCherry, Cas9, and other sequences of clients' interest.
For more information about off-the-shelf mRNA products, please click here: https://www.portonadvanced.com/research-preclinical/pre-made-custom-made-vectors/mrna-and-cicrrna-to/.

GMP production must adhere to strict global regulatory guidelines set by authorities such as the FDA, EMA, and others. At Porton Advanced, we closely follow these regulations throughout the entire production process, from template generation to final fill-and-finish. This adherence ensures compliance and facilitates smooth regulatory approval for both clinical and commercial use. We have a proven track record of assisting our clients in obtaining over 16 IND approvals in China, the U.S., and New Zealand.

At Porton Advanced, quality assurance is our top priority. Our GMP mRNA manufacturing process involves thorough quality tests at every stage. These include assessments of mRNA integrity, evaluations of LNP encapsulation efficiency, and stability studies to ensure that each batch meets the highest standards. At the same time, our advanced quality control system guarantees that the entire production process adheres to GMP regulations.