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mRNA purification is a key step in GMP mRNA production, ensuring that the mRNA produced has the highest purity, integrity and concentration required for its use in research, clinical trials or therapeutic applications. Creative Biogene utilizes a variety of optimized purification methods to maximize the quality and purity of GMP mRNA production to support our clients' project development demands.
Purification after in vitro transcription (IVT) is important for the safety and efficacy of the final mRNA product. During in vitro transcription, unwanted impurities, such as DNA template, RNA polymerase, nucleotides and salts, may be present in the mRNA sample. The purification process removes these contaminants that have the potential to affect the stability, efficiency or biological activity of mRNA, ensuring that mRNA has the highest purity. In addition, the purification step helps to ensure the integrity of the mRNA and helps to obtain a concentrated mRNA sample.
Creative Bogene utilizes a variety of advanced purification methods and technologies to support GMP mRNA production, our specific methods include but are not limited to the following:
Chromatography is a common purification process used by Creative Biogene. A variety of techniques based on different principles are available, including affinity chromatography, ion pair reverse-phase chromatography (IPC), ion exchange chromatography (IEC), anion chromatography purification, and hydrophobic chromatography purification. These methods effectively remove DNA template, abnormal RNA, residues and impurities from the mRNA production process with higher reproducibility, recovery and purity and better scalability.
Using magnetic beads bound to mRNA, separation can be easily performed using magnetic fields. Oligo dT is commonly used for mRNA capture in laboratory applications. This sequence binds to the poly-A tails present in the mRNA. Chromatographic beads with immobilized oligo dT could thus be used for the process scale purification using affinity chromatography: the poly-A tails of the single stranded mRNA produced during IVT would bind to the stationary phase while impurities are washed out.
Small size impurities can also be removed when concentrating or percolating solutions through the use of tangential flow filtration (TFF). This method is fast, requires less equipment, and is cost-effective, making it an attractive option for small-scale GMP mRNA production processes.
Creative Biogene's experienced project experts can help you solve any challenges you encounter during mRNA purification, ensuring that mRNA stability is maintained during GMP mRNA production while maximizing yield and purity. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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