Quality Control of mRNA Product

Creative Biolabs is a leading service provider that focuses on mRNA therapeutic development. With years of experience in this area, we are capable of offering a full package of services to support your mRNA product development, including but not limited to custom mRNA synthesis, custom mRNA modification, custom delivery vehicle for mRNA, custom mRNA-based cell reprogramming service, custom mRNA stability test service. Here, we are happy to introduce our quality control (QC) service for mRNA products.

Quality Control Criterion of mRNA Products

During past years, mRNA products have come into focus as a potential new drug class to deliver genetic information. To date, many mRNA-based therapeutics, such as cancer vaccine development and gene therapy therapeutics, have been developed for multiple applications. However, all genetic sequences are susceptible to random mutation. According to the regulatory requirements of the FDA, strict quality control should be conducted in the preclinical phase to assure product safety, identity, quality, purity, and strength (including potency). Moreover, orthogonal analytical techniques should be applied to assess the quality of all components including all materials and components used for the manufacture of a gene therapy product such as vectors, reagents, and excipients.

Quality Control Services Provided by Creative Biolabs

As a leading service provider in mRNA development, Creative Biolabs provides mRNA product quality control services to support your drug development. With a heritage of advanced pharmaceutical product development platforms and a comprehensive range of analytical techniques, we have successfully developed GMP validated analytical methods including：

• General methods, such as identification, assay, content uniformity, residual solvents, and elemental impurities;
• Compendial methods including appearance, pH, osmolality, particulate matter, container closure integrity, sterility, and bacterial endotoxins;
• Particularly, our professional experts provide mRNA specific methods including integrity, potency, capping efficiency, residual DNA template, residual dsRNA, and delivery system testing.

Features of Our Services

• GMP testing platform
• Ph.D. level scientists and skillful technicians
• Customized proposals to meet each client’s requirements
• Short turn around time with best after-sale service

Creative Biolabs is committed to offering comprehensive quality control services of mRNA products. Based on advanced technology platforms and numerous GMP analytical methods, our professional scientists can test an mRNA drug substance or drug product to help you confidently assess batch to batch manufacture and process repeatability as well as the quality of mRNA produced. In addition to quality control analysis, we also provide customized mRNA chemical synthesis and IVT synthesis services for global researchers. If you are interested in the service we offer, please feel free to contact us for more details.

Reference

1. Antony, J.S.; et al. Modified mRNA as a new therapeutic option for pediatric respiratory diseases and hemoglobinopathies. Molecular and cellular pediatrics. 2015, 2(1): p.11.