Takara Bio Europe has launched new High Quality (HQ) grade mRNA production enzymes “T7 RNA polymerase, HQ” and "Pyrophosphatase (inorganic), HQ" suitable for pre-clinical and process development in mRNA vaccine and therapeutic manufacturing.
HQ grade enzymes have features more similar to GMP grade quality (e.g. the same set of quality tests as GMP grade, see details below) than RUO grade enzymes, facilitating a smooth transition to GMP-grade manufacturing. Additionally, the high volume format (1mL/tube) offers convenience for scaling up processes.
The firm is expanding its lineup of HQ enzymes to support pre-clinical and process development stages in mRNA production, including another HQ grade product "Recombinant RNase Inhibitor, HQ", set to be launched soon. It also plans to sequentially provide GMP grade enzymes suitable for active pharmaceutical ingredients for manufacturing mRNA vaccines and therapeutic drugs.
GMP grade reagents are manufactured and quality controlled in accordance with the GMP guidelines of PIC/S (Pharmaceutical Inspection Agreement and Pharmaceutical Inspection Joint Scheme). GMP grade reagents are suitable for manufacturing active pharmaceutical ingredients for clinical trials.